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The
RECEIVED
'SEP i^ 1993
LAW LIBRARY
NORTH CAROLINA {±
REGISTER
IN TfflS ISSUE
EXECUTIVE ORDER
ITJTM
hriow y
PROPOSED RULES
Administration
Environment, Health, and Natural Resources
Human Resources
Insurance
Justice
Refrigeration Examiners
State Treasurer
Transportation
RRC OBJECTIONS
RULES INVALIDATED BY JUDICIAL DECISION
CONTESTED CASE DECISIONS
ISSUE DATE: September 15, 1993
Volume 8 • Issue 12 • Pages 1007 - 1184
INFORMATION ABOUT THE NORTH CAROLINA REGISTER AND ADMTNTSTRATTVE CODE
NORTH CAROLINA REGISTER TEMPORARY RULES
The North Carolina Register is published twice a month and
contains information relating to agency, executive, legislative and
judicial actions required by or affecting Chapter 150B of the
Genera] Statutes. All proposed administrative rules and notices of
public hearings filed under G.S. 150B-21.2 must be published in
the Register. The Register will typically comprise approximately
fifty pages per issue of legal text.
State law requires that a copy of each issue be provided free of
charge to each county in the state and to various state officials and
institutions.
The North Carolina Register is available by yearly subscription
at a cost of one hundred and five dollars (S105.00) for 24 issues.
Individual issues may be purchased for eight dollars (S8.00).
Requests for subscription to the North Carolina Register should
be directed to the Office of Administrative Hearings,
P. 0. Drawer 27447, Raleigh, N. C. 2761 1-7447.
Under certain emergency conditions, agencies may issue
temporary rules. Within 24 hours of submission to OAH, the
Codifier of Rules must review the agency's written statement of
findings of need for the temporary rule pursuant to the provisions in
G.S. 150B-21.1. If the Codifier determines that the findings meet
the criteria in G.S. 150B-21.1, the rule is entered into the NCAC. If
the Codifier determines that the fmdings do not meet the criteria,
the rule is returned to the agency. The agency may supplement its
findings and resubmit the temporary rule for an additional review
or the agency may respond that it will remain with its initial
position. The Codifier, thereafter, will enter the rule into the
NCAC. A temporary rule becomes effective either when the
Codifier of Rules enters the rule in the Code or on the sixth
business day after the agency resubmits the rule without change.
The temporary rule is in effect for the period specified in the rule or
180 days, whichever is less. An agency adopting a temporary rule
must begin rule-making procedures on the permanent rule at the
same time the temporary rule is filed with the Codifier.
ADOPTION AMENDMENT, AND REPEAL OF
RULES
NORTH CAROLINA ADMINISTRATIVE CODE
TTie following is a generalized statement of the procedures to be
followed for an agency to adopt, amend, or repeal a rule. For the
specific statutory authority, please consult Article 2A of Chapter
150B of the General Statutes.
Any agency intending to adopt, amend, or repeal a rule must
first publish notice of the proposed action in the North Carolina
Register. The notice must include the time and place of the public
hearing (or instructions on how a member of the public may request
a hearing); a statement of procedure for public comments; the text
of the proposed rule or the statement of subject matter; the reason
for the proposed action; a reference to the statutory authority for the
action and the proposed effective date.
Unless a specific statute provides otherwise, at least 15 days
must elapse following publication of the notice in the North
Carolina Register before the agency may conduct the public
hearing and at least 30 days must elapse before the agency can take
action on the proposed rule. An agency may not adopt a rule that
differs substantially from the proposed form published as part of
the public notice, until the adopted version has been published in
the North Carolina Register for an additional 30 day comment
period.
When final action is taken, the promulgating agency must file
the rule with the Rules Review Commission (RRC). After approval
by RRC, the adopted rule is filed with the Office of Administrative
Hearmgs (OAH).
A rule or amended rule generally becomes effective 5 business
days after the rule is filed with the Office of Administrative
Hearings for publication in the North Carolina Administrative Code
(NCAC).
Proposed action on rules may be withdrawn by the promulgatmg
agency at any time before final action is taken by the agency or
before filing with OAH for publication in the NCAC.
The North Carolina Administrative Code (NCAC) is a
compilation and index of the administrative rules of 25 state
agencies and 38 occupational licensing boards. The NCAC
comprises approximately 15,000 letter size, single spaced pages of
material of which approximately 35% of is changed annually.
Compilation and publication of the NCAC is mandated bv G.S.
150B-21.18.
The Code is divided into Titles and Chapters. Each state agency
is assigned a separate title which is further broken down by
chapters. Title 21 is designated for occupational licensing boards.
The NCAC is available in two formats.
(1) Single pages may be obtained at a minimum cost of
two dollars and 50 cents (S2.50) for 10 pages or less,
plus fifteen cents (50.15) per each additional page.
(2) The full publication consists of 53 volumes, totaling in
excess of 15.000 pages. It is supplemented monthly
with replacement pages. A one year subscription to the
full publication including supplements can be
purchased for seven hundred and fifty dollars
(S750.00). Individual volumes may also be purchased
with supplement service. Renewal subscriptions for
supplements to the initial publication are available.
Requests for pages of rules or volumes of the NCAC should be
directed to the Office of Administrative Hearings.
CITATION TO THE NORTH CAROLINA
REGISTER
The North Carolina Register is cited by volume, issue, page
number and date. 1:1 NCR 101-201, April 1, 1986 refers to
Volume 1, Issue 1, pages 101 through 201 of the North Carolina
Register issued on April 1, 1985.
FOR INFORMATION CONTACT: Office of
Administrative Hearings. ATTN: Rules Division, P.O.
Drawer 27447, Raleigh. North Carolina 27611-7447, (919)
733-2678.
NORTH
CAROLINA
REGISTER
Office of Administrative Hearings
P. O. Drawer 27447
Raleigh, North Carolina 27611-7447
(919) 733-2678
Julian Mann III,
Director
James R. Scarcella Sr.,
Deputy Director
Molly Masich,
Director ofAPA Services
Staff:
Ruby Creech,
Publications Coordinator
Teresa Kilpatrick,
Editorial Assistant
Jean Shirley,
Editorial Assistant
ISSUE CONTENTS
I. EXECUTIVE ORDER
Executive Order 23 1007
11. PROPOSED RULES
Administration
State Employees Combined
Campaign 1008
Environment, Health, and
Natural Resources
Health Services 1098
Human Resources
Facility Services 1014
Mental Health, Developmental
Disabilities and Substance Abuse
Services 1086
Social Services 1091
Insurance
Financial Evaluation Division . . . 1093
Life and Health Division 1094
Special Services Division 1096
Justice
Departmental Rules 1096
Licensing Board
Refrigeration Examiners 1148
State Treasurer
Retirement System 1146
Transportation
Motor Vehicles, Division of ... . 1145
III. RRC OBJECTIONS 1151
IV. RULES INVALIDATED BY
JUDICIAL DECISION 1155
V. CONTESTED CASE DECISIONS
Index to ALJ Decisions 1156
Text of Selected Decisions
92 OSP 1606 1163
93 HRC 0167 11^
93 CPS0205 1171
93 EHR0276 1176
VI. CUMULATIVE INDEX 1182
NORTH CAROLINA REGISTER
Publication Schedule
(July 1993 - May 1994)
Volume
and
Issue
Number
Issue
Date
Last Day
for
Filing
Last Day
for Elec-tromc
Filmg
Earliest
Date for
PubUc
Hearing
15 days
from
notice
* End of
Required
Comment
Penod
30 days
from
notice
Iflst Day
to Submit
to RRC
** Earliest
Effective
Date
8:7 07/01/93 06/10/93 06/17/93 07/16/93 08/02/93 08/20/93 10/01/93
8:8 07/15/93 06/23/93 06/30/93 07/30/93 08/16/93 08/20/93 10/01/93
8:9 08/02/93 07/12/93 07/19/93 08/17/93 09/01/93 09/20/93 11/01/93
8:10 08/16/93 07/26/93 08/02/93 08/31/93 09/15/93 09/20/93 11/01/93
8:11 09/01/93 08/11/93 08/18/93 09/16/93 10/01/93 10/20/93 12/01/93
8:12 09/15/93 08/24/93 08/31/93 09/30/93 10/15/93 10/20/93 12/01/93
8:13 10/01/93 09/10/93 09/17/93 10/18/93 11/01/93 11/22/93 01/04/94
8:14 10/15/93 09/24/93 10/01/93 11/01/93 11/15/93 11/22/93 01/04/94
8:15 11/01/93 10/11/93 10/18/93 11/16/93 12/01/93 12/20/93 02/01/94
8:16 11/15/93 10/22/93 10/29/93 11/30/93 12/15/93 12/20/93 02/01/94
8:17 12/01/93 11/05/93 11/15/93 12/16/93 01/03/94 01/20/94 03/01/94
8:18 12/15/93 11/24/93 12/01/93 12/30/93 01/14/94 01/20/94 03/01/94
8:19 01/03/94 12/08 '93 12/15/93 01/18/94 02/02/94 02/21/94 04/01/94
8:20 01/14/94 12/21/93 12/30/93 01/31/94 02/14/94 02/21/94 04/01/94
8:21 02/01/94 01/10/94 01/18/94 02/16/94 03/03/94 03/21/94 05/01/94
8:22 02/15/94 01/25/94 02/10/94 03/02/94 03/17/94 03/21/94 05/01/94
8:23 03/01/94 02/08/94 02/15/94 03/16/94 03/31/94 04/20/94 06/01/94
8:24 03/15/94 02/22/94 03/10/94 03/30/94 04/14/94 04/20/94 06/01/94
9:1 04/04/94 03/11/94 03/18/94 04/19/94 05/04/94 05/20/94 07/01/94
9:2 04/15/94 03/24/94 03/31/94 05/02/94 05/16/94 05/20/94 07/01/94
9:3 05/02/94 04/11/94 04/18/94 05/17/94 06/01/94 06/20/94 08/01/94
9:4 05/16/94 04/25/94 05/02/94 05/31/94 06/15/94 06/20'94 08/01/94
Note: Time is computed according to the Rules of Civil Procedure, Rule 6.
* An agency must accept comments for at least 30 days after the proposed text is published or until the date
of any public hearing, whichever is longer. See G.S. 150B-21. 2(f) for adoption procedures.
** The "Earliest Effective Date " is computed assuming that the agency follows the publication schedule above,
that the Rules Re\ie^v Commission approves the rule at the next calendar month meeting after submission, and
that RRC delivers the rule to the Codifier of Rules five (5j business days before the 1st business day of the next
calendar month.
Rexised 07/93
EXECUTIVE ORDER
EXECUTIVE ORDER NUMBER 23
PUBLIC SCHOOL ADMINISTRATOR
TASK FORCE
WHEREAS, this Administration has a goal of
doing more with less in our public schools by
increasing effectiveness and efficiency;
WHEREAS, business and industry leaders have
built up valuable expertise in using this strategy;
WHEREAS, the most effective and efficient ratio
of local public school administrators to teachers
and students is not icnown;
NOW, THEREFORE, by the power vested in me
as Governor by the Constitution and laws of North
Carolina, IT IS ORDERED:
Section 1. Recission of Executive Order.
Executive Order 12, dated May 12, 1993,
hereby rescinded.
IS
(b)
Section 2. Establishment.
There is hereby established a Public School
Administrator Task Force ("Task Force").
Section 3. Membership and Chair.
The Task Force shall consist of the following
members:
(a) twelve business and industry leaders with
experience in improving effectiveness and
efficiency in their organizations appointed
by the Governor;
nine representatives of the public school
system, appointed by the Governor,
consisting of: three superintendents,
three principals, and three teachers. A
small, medium, and large public school
system shall be represented in each cate-gory;
the Director of State Personnel, or his
designee;
the State Auditor, or his designee;
the Superintendent of Public Instruction,
or his designee; and
the State Budget Officer, or his designee.
(c)
(d)
(e)
(f)
school administrators to teachers and
students;
(b) Determine the ratio necessary to effec-tively
and efficiently administer quality
education at the local level;
(c) Develop guidelines for local public
school administrators to follow in imple-menting
more effective and efficient
administration; and
(d) Report its findings and recommendations
to the Joint Legislative Education Over-sight
Committee and to the State Board
of Education by May 1, 1994.
Section 5. Administration and Expenses.
The Task Force members shall be reimbursed for
reasonable travel and other expenses as allowed by
North Carolina law. Administrative and staff
support for the Task Force shall be principally
provided by the Office of the Governor. Addition-al
staff support may be provided by other state
agencies as required.
This order is effective immediately, and shall
terminate upon completion of the Task Force's
reported findings and recommendations.
Done in the Capital City of Raleigh, North
Carolina, this 26th day of August, 1993.
The chair shall be designated by the Governor,
and the Task Force shall meet at the call of the
Chair.
Section 4. Duties.
The Task Force shall have the following duties:
(a) Analyze existing ratios of local public
8:12 NORTH CAROLINA REGISTER September 15, 1993 1007
PROPOSED RULES
TITLE 1 - DEPARTMENfT OF
ADMINISTRATION
ISotice is hereby given in accordance with G.S.
150B-21.2 that the State Employees Combined
Campaign Advisory Committee intends to amend
rules cited as 1 NCAC 35 .0101 - .0103, .0201 -
.0204, .0301 - .0307 and repeal rule cited as 1
NCAC 35 . 0303. Existing Rules 1 NCAC 35 . 0301
- .0302, .0401 - .0407 are proposed to be recodi-fied
as .0203 - .0204, .0301 - .0307. This notice
reflects those recodification changes.
A he proposed effective date of this action is
December 1. 1993.
Ike public hearing will be conducted at 10:00
a.m. on October 4, 1993 at the State Library
Building, Room 211, 109 East Jones Street, Ra-leigh,
NC
ixeason for Proposed Action: To clarify and
consolidate rules applying to charitable organiza-tions
applying for inclusion in the State Employees
Combined Campaign.
i^omment Procedures: Written comments should
be submitted to: Secretary Betty Ray McCain,
Department of Cultural Resources, 109 East Jones
Street, Raleigh, NC 27603.
CHAPTER 35 - STATE EMPLOYEES
COMBINED CAMPAIGN
SECTION .0100 - PURPOSE AND
ORGANIZATION
.0101 DEFINITIONS
The puqjoso of the State Employees Combinod
Campaign ia to allow state employees the opportu
nity to contribute to charitable non partisan organ!
zations in an orderly and uniform process.—The
contributions are in turn granted to tho se charities
selected by the S.E.C.C. Advisory Committee.
These Regulations apply only to those campaigns
in which employees are asked to malce charitable
donations using payroll deduct ion as method of
payment.
(a) "Charitable organization." A non-partisan
organization that is tax-exempt for both the IRS
and N.C. tax purposes. The organization must
receive contributions that are tax deductible by the
donor.
(b) "Audit" or "audited financial statement." An
examination of financial statements of an organiza-tion
b^ a CPA. conducted in accordance with
generally accepted auditing standards, to determine
whether, in the CPAs opinion, the statements
conform with generally accepted accounting
principles or, if applicable, with another compre-hensive
basis of accounting.
(c) "State Employees Combined Campaign" or
"SECC. " The official name of the state employees
charitable fund-raising drive.
(d) "Federation" or "Federated Group" means a
group of voluntary charitable human health and
welfare agencies organized for purposes of supply-ing
common fund-raising, administrative, and
management services to its constituent members.
Statutory Authority G.S. 143-3.3; 143B-10.
.0102 PURPOSE
The official name of the state employoco charita
feie
—
fundmising—drive
—
te—tbe
—
State
—
Employees
Combined Campaign (SECC).
The purpose of the State Employees Combined
Campaign is to allow state employees the opportu-nity
to contribute to charitable non-partisan organi-zations
in an orderly and uniform process. The
contributions are in turn granted to those charities
selected by the SECC Advisory Committee. The
SECC is authorized to conduct a payroll deduction
fund-raising effort among state employees.
Statutory Authority G.S 143-3.3: 143B-10.
.0103 ORGANIZATION OF THE
CAMPAIGN
The Campaign Organization is as follows:
(I) Chair. Each year the governor Governor
may appoint a State Statewide Combined
Campaign Director Chair from one of the
Executive Cabinet^^ Council of State,
System of Community Colleges, or Uni-versity
Administration agencies. The
Campaign Director Chair or the Cam-paign
Director's Chair's designee will
serve as chair director of the campaign.
The responsibilities of the chair Chair
include setting the dates and approving
the published materials for the Combined
Campaign, contracting for the Statewide
Campaign Manager, and appointing and
serving as chair of the S.E.C.C. advisory
committee SECC Advisory Committee .
1008 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
For the purposes of selecting a Statewide
Campaign Manager, the Statewide Com-bined
Campaign Chair will consider the
following criteria:
(a) The organization must have demonstrat-ed
ability to manage large-scale fund-raising
campaigns.
(b) The organization must have the ability
and willingness to work with a state-wide
system of local organizations
capable of effectively managing local
combined campaigns and relating to the
Statewide Campaign Manager.
(c) The organization must have an accept-able
record of financial accountability.
(d) The organization must be a tax-exempt
organization under the Internal Revenue
Code.
(e) The organization must be willing and
able to provide a bond in an amount
satisfactory to the SECC Advisory
Committee to protect the participant
organizations and donors.
(2) SECC Advisory Committee. This ongo-ing
committee serves as a central applica-tion
point for all charitable organizations
applying to participate in the S.E.C.C.
SECC . The committee recommends
overall policy for the campaign to the
Governor, the Statewide Campaign ©i-reotor
Chair, and necessary state agencies
and recommends the criteria for partici-pation
by charitable organizations. The
committee reviews the recommendations
made by the Statewide Campaign Manag-er
and accepts or rejects its recommenda-tions.
The committee may, m its discre-tion,
require the Statewide Campaign
Manager to provide a bond, as provided
in Item (l)(e) of this Rule. The commit-tee
is composed of 10 state employee
members appointed by the Statewide
Campaign Director Chair. Members of
the committee will initially oervo stag
gorod torms of one, two, and three calen
dar years determined by the Campaign
Director.—As each member's term ex
pires,—tfee
—
replacement—members—wttt
serve a three year calendar appointment.
Members serve three-year staggered
terms at the pleasure of the Statewide
Campaign Chair. If a vacancy occurs,
the Statewide Campaign Chair shall
appoint a replacement to fill the unex-pired
term. Any member may be reap-pointed
at the end of his or her term.
(3) Statewide Campaign Manager. The
Statewide Campaign Manager is selected
by the Statewide Campaign Chair. The
duties of the Statewide Campaign Manag-er
include, but are not limited to. the
following:
(a) serving as the financial administrator of
the SECC;
(h) determining if the applicant agencies
meet the requirements of Rule .0202 of
this Chapter;
(c) submitting to the Statewide Campaign
Chair the name of an organization to
serve as Local Campaign Manager;
(d) providing the necessary supervision of
data processing services in order to
process all payroll deduction pledge
forms of state employees;
(e) receiving reports from the Local Cam-paign
Manager;
(f) transmitting to each Local Campaign
Manager its share of the state employ-ees
payroll deduction funds;
(g) printing and distributing the pledge
form, the campaign report form and
collection envelopes to the Local Cam-paign
Manager;
(h) maintaining an accounting of all funds
raised and submitting an interim unau-dited
end-of-campaign report of the
following:
(i) amounts contributed and pledged;
(ii) number of contributions; and
(iii) amounts distributed to each participat-ing
agency;
(i) Once applications for acceptance into
the campaign have been recommended
to the SECC Advisory Committee by
the Statewide Campaign Manager, a list
of all accepted organizations will be
prepared by the Statewide Campaign
Manager and distributed to all appli-cants.
Serves as the financial administrator for
th e Combmed Campaign and as such is
responsible for receiving reports from
the—leeal
—
Combined Campaigns,—fer
transmitting to each local campaign its
share of the state employees payroll
deduction funds, and for preparing an
end of campaign report which summa
rizes all fiscal campaign activity includ
ing local audits.—TTie Statewide Cam
paign Manager is also responsible for
8:12 NORTH CAROLINA REGISTER September 15, 1993 1009
PROPOSED RULES
tbe—printing—and
—
distribution—of the
pledge fonii. campaign report form,
and oolleotion envelopes.
(4) Local Campaign Chair. Tlie Governor,
if asked by the local charitable organiza-tions
accepted into the Combined Cam-paign,
may appoint an area representative
from either state government or the
University of North Carolina system to
serve as the looal chair Local Chair .
This person will be responsible for form-ing
a looal—advisory committee Local
Advisory Committee for recruitment of
volunteer state employeesT^ The Local
Chair and the Local Advisory Committee
are jointly responsible for the approval of
local campaign literature, the establish-ment
of local goals as needed, and the
distribution of any undesignated funds
made available for distribution.
(5) Local Campaign Manager. Onoe applioa
tions for acceptance into the campaign
have boon recommended to th e Commit
too by the Statewide Campaign Manager,
a list of all accepted organizations will be
prepared—by
—
the Statewide
—
Campaign
Manager and distributed to all applicants.
The State Campaign Manager will submit
to the State Combined Campaign Director
the name of an agency to serve as the
local campaign manager. The Campaign
Director Chair will approve or reject the
State Campaign Manager's recommenda-tion
and has the right to name the Local
Campaign Manager. The Local Cam-paign
Manager must identify itself on all
printed materials as the local manager of
the SECC rather than of any other orga-nization.
(a) For the purpose of selecting a Local
Campaign Manager, the Statewide
Campaign Chair and Statewide Cam-paign
Manager will consider the follow-ing
criteria:
(i) be a local organization willing to
conduct a local SECC;
(ii) comply with the terms of the
State/Local Managers contract;
(iii) have a broad base of community and
state employee support and volunteer
involvement;
(iv) have a demonstrated ability and suc-cessful
history of managing fund-raising
campaigns that include:
(A) development of campaign strate-
ID)
im
IE)
development of campaign materi-als;
development of volunteer cam-paign
structures;
training of volunteer solicitors;
have a financial structure and
resources that can efficiently
manage, account for, and disburse
funds;
be a participant organization of
the campaign;
must be able to develop financial
relationships with a network of
statewide organizations so as to
ensure the orderly transmittal,
disbursement, accounting of, and
reporting of donations and pledg-es.
fb) The local—manager Local Campaign
Manager is responsible for assisting the
Local Campaign Chair and Local Cam-paign
Advisory Committee in the print-ing
and distribution of campaign litera-ture,
the collection of pledge reports
and envelopes from the state agency
volunteers, the development of cam-paign
reports, and the forwarding of
one copy of each payroll deduction
pledge to the Statewide Campaign
Manager. In addition, an end of cam-paign
report shall be sent to the State-wide
Campaign Manager for inclusion
in the required fiscal reports.
(c) The Local Campaign Manager is re-sponsible
for the following:
(i) establishing an account with a bank in
order to receive deposits of collected
funds; and
(ii) distributing the funds from the contri-butions
in accordance with designa-tions
made by state employees. Un-designated
funds will be distributed
according to APA regulations govern-ing
the SECC.
Note: A contract between the state and the State-wide
Campaign Manager, and the state Statewide
and local manager Local Campaign Managers , will
be executed in order to develop an acceptable audit
trail. The contracts will allow a reasonable charge
for campaign expenses to be claimed by the State-wide
Campaign Manager and the local manager
Local Manager. All terms and conditions of these
contracts are subject to review and approval by the
Statewide Campaign Director Chair .
1010 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
Statutory Authority G.S. 143-3.3; 143B-10.
SECTION .0200 - APPLICATION PROCESS
AND SCHEDULE
.0201 APPLICATIONS
To be eligible to participate in the State Employ-ees
Combined Campaign, an organization must
apply annually for consideration, either as an
independent organization or as a group of organi
zations federation .
Statutory Authority G.S. 143-3.3; 143B-10.
.0202 CONTENT OF APPLICATIONS
(a) All organizations seeking inclusion in the
campaign must submit an application to the state
campaign. The application must include a com-pleted
State Employees Combined Campaign
Certificate of Compliance, provided by the State-wide
Campaign Manager. Included in or attached
to the Certificate of Compliance must be:
(1) A letter from the board of directors
requesting inclusion in the campaign.
(2) A complete description of services
provided, the service area of the orga-nization,
and fund-raising/administrative
costs.
(3) The most recent audited financial state-ment
prepared by a CPA within the
past two years. The year end of such
audited financial statement must be no
earlier than two years prior to the
current year's campaign date. The
SECC Advisory Committee may grant
an exception to this requirement if an
organization has filed its Articles of
Incorporation with the Secretary of
State's Oflice since March i of the
preceding year of the current campaign.
(4) A board statement of assurance of non-discrimination
of employment, board
membership and client services.
(5) A description of the origin, purpose and
structure of the organization.
(6) A list of the current members of the
board, including their addresses.
(7) A letter from the board of directors
certifying compliance with the eligibili-ty
standards listed in Paragraph (b) of
this Rule.
(8) When a federated fund-raising organiza-tion
submits an application they may
submit the credentials of the federation
only, not each member agency. By the
submission of such, the federations
certify that all of their member agencies
comply with all the SECC regulations,
unless there are exceptions. If there are
exceptions to the requirements, the
federations must disclose such and
explain to the satisfaction of the State-wide
Combined Campaign Advisory
Committee the reasons for the excep-tion,
(b) Organizations must meet the following
criteria to be accepted as participants in the Com-bined
Campaign:
(1) The organization must be licensed to
solicit funds in North Carolina if a
license is required by law .
(2) Have Must provide written proof of tax
exempt status for both the IRS federal
and N.C. tax purposes. Organizations
must certify that contributions from
state employees are tax deductible by
the donor under N.C. and federal law.
(3) Must prepare and make available to the
general public an annual audited finan-cial
statement. , report or IRS Form
99Gt The SECC Advisory Committee
may grant an exception to this require-ment
if an organization has filed its
Articles of Incorporation with the Sec-retary
of State's Office since March \
of the preceding year of the current
campaign. An exception to thi s ro
quirement is provided for any organiza
tion whioh—hoo filed its—Articles of
Inoorpomtion—with—the
—
Secretary—ef
State's Offico as of March 1, of the
preceding year of the current campaign.
(4) If fund-raising and administrative ex-penses
are in excess of 25 percent of
total revenue, the organization must
demonstrate to the satisfaction of the
SECC that those expenses for this
purpose are reasonable under all the
circumstances of the case.
(5) Must certify that all publicity and pro-motional
activities are truthful and non-deceptive
and that all material provided
to the SECC is truthful and non-decep-tive
.
(6) Must agree to maintain the confidential-ity
of the contributor list.
(7) Must permit no payments of commis-sions,
kickbacks, finders fees, percent-ages,
bonuses, or overrides for fund;
raising, and permit no paid solicitations
8:12 NORTH CAROLINA REGISTER September 15, 1993 1011
PROPOSED RULES
of the public.
(8) Must have a policy of non-discrimina-tion
on the basis of race, color, reli-gion,
sex, age, national origin or physi-cal
or mental handicap disability for
clients of the agency, employees of the
agency and members of the governing
board.
(9) Must provide benefits or services within
the local community, meaning that
employees in the solicitation area or
their femilies should be able to receive
benefits or services from the agency
within a reasonable distance , or receive
benefits—from—voluntary—agonoios .
Examples of services are include :
(a) (A) research and education in the
health and welfare or education fields;
(fe) £B} family and child care services;
{©) iC) protective services for children
and adults;
(4) (D) services for children and adults in
foster care;
^ £E} services related to the manage-ment
and maintenance of the home;
{^ £F} day care services for adults and
children;
(g) (G) transportation services, informa-tion
referral and counseling services;
(b) (H) the preparation and delivery of
meals;
(i) £1} adoption services;
{j) (J) emergency shelter care and relief
services;
{k) (K) safety services;
(i) £L) neighborhood and community
organization services;
(ffl) (M) recreation services;
(fi) (N) social adjustment and rehabilita-tion
services;
{e) £0} health support services; or
{p) ££} a combination of services de-signed
to meet the needs of special
groups such as the elderly or handi
capped disabled .
However, an international organization which
provides health and welfere services overseas,
whose activities do not require a local presence
and which meet other eligibility criteria, may be
accepted for participation in the campaign.
Statutory Authority G.S. 143-3.3; MSB-10.
tOMI .0203 SCHEDULE
Complete applications must be submitted to the
State Statewide Combined Campaign Advisory
Committee by February 15 annually to be included
in the fall campaign. Incomplete applications may
not be considered by the committee. The Chair
will forward all application materials to the State-wide
Campaign Manager within three working
days after the closing deadline. The Statewide
Campaign Manager will report to the Committee
its recommendation on each application within
three weeks of the closing deadline. The Commit-tee
shall affirm or reject each recommendation by
the Statewide Campaign Manager and will inform
the Statewide Campaign Manager of its decisions.
Statutory Authority G.S. 143-3.3; 143B-10.
.MQ2 .0204 RESPONSE
All applicants will be notified by the Statewide
Campaign Manager of the Committee's decision
within 50 45 days of the closing deadline. An
applicant who is dissatisfied with the determination
of its application may file an appeal to the State
Advisory Committee within 10 days of the notifi-cation
dispatch postmark date. An applicant who
is dissatisfied with either the committee's
Committee's decision or the appeal determination
of the committee Committee may commence a
contested case by filing a petition under 150B-23
within 60 days of notification dispatch postmark
date of the Committee's decision.
Statutory' Authority' G.S 143-3.3; 1438-10.
.0303
AH-FORM
AND CONTENT OF
APPLICATION
organizations seeking funding must submit an
application to th e state campaign. The application
must—include—the
—
State—Employees—Combined
Campaign Certificate of Compliance.—Included in
or attached to the Certificate of Compliance must
be-w-
-A etter—from—the
—
board—of directors
indicating interest.
(3) A complete description of services pro
vided. and th e s ervice area of th e organi
zntion.
{54 The most recent audited financial state
ment prepared by a CPA.—An exception
to this requireme nt is provided for any
organization which has filed its Articles
of Inoorpomtion with th e Secretary of
State's—Office
—
as of March—]-,—of th e
preceding year of the current campaign.
f4) A board stateme nt of assurance of non
discrimination.
1012 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
^^
m-f^
A desoription of tho origin, purpooe and
Btruoturo of the organization.
A list of the current members of the
board, including addresses.
A letter oortilying compliance with the
eligibility standards listed in Rule .0202
of this—Chapter—including—ta*
—
exempt
status, licensing, and showing the per
oentage of funds expended in the catego
ries of Program and Service, Manage
ment and General (Administrative) and
Fundmising.
Statutory Authority G.S. 143-3.3; 143B-10.
SECTION .MOO .0300 - GENERAL
PROVISIONS
.«401 .0301 OTHER SOLICITATION
PROfflBITED
Not more than one on-the-job solicitation for
funds will be made in any year at any location on
behalf of participating SECC agencies. The
prohibition does not include Red Cross sponsored
Bloodmobiles or employee association solicitations.
The State Employee Combined Campaign is the
only authorized payroll deduction fund raising
effort among state omployoos.
Payment may be made by payroll deduction,
cash, pledge, or personal check. If an employee
chooses to use the payroll deduction method of
contributing, he/she must agree to having have the
deduction continue for one year with equal
amounts being talcen deducted from each check
(monthly or biweekly depending on the payroll).
All deductions will start with the January payroll
and continue through December. If the employee
discontinues employment, or actively chooses to
discontinue payment, the state will not be responsi-ble
for the collection of the unpaid pledge. No
deduction will be made for any period in which the
employee's net pay, after all legal and previously
authorized deductions, is insufficient to cover the
allotment. No adjustments will be made in subse-quent
periods to make up for deductions missed.
Statutory Authority G.S 143-3.3; 143B-10.
t0404 .0304 CAMPAIGN LITERATURE
Each charitable organization accepted as a part of
the campaigUT must provide adequate information
about its servicesT including administrative/fund-raising
costs, to the local campaign manager Local
Campaign Manager for use in the local campaign.
Statutory Authority G.S 143-3.3; 143B-10.
Statutory Authority G.S 143-3.3; 143B-10.
t0403 .0302 COERCIVE ACTIVITIES
PROfflBITED
(a) In order to insure that donations are made on
a voluntary basis, actions that do not allow free
choice or that create an impression of required
giving are prohibited. Peer solicitation is encour-aged.
Employee Employees gifts are kept confi-dentialT^
except that employees may opt to have
their designated contributions acknowledged by the
recipient organizations.
(b) The following activities are not permitted:
(1) The Providing providing and using of
contributor lists for purposes other than
the routine collection^ and forwarding^
and acknowledgement of contributions.
(2) TTie establishment of personal dollar
goals or quotas.
(3) The developing and using of lists of
non-contributors.
Statutory Authority G.S. 143-3.3; 143B-10.
t0403 .0303 PAYMENT METHOD AND
TERMS OF CONTRIBUTION
t040S .0305 DESIGNATION CAMPAIGN
Each employee will be given the opportunity to
designate which agency or group of agencies
should benefit from his or her contribution to the
State Employees Combined Campaign. Each
employee will be given a listing list of the ap-proved
agencies in the campaign in order to help
them make the decision.
Statutory Authority G.S. 143-3.3; 143B-10.
.0406 .0306 DISTRIBUTION OF
UNDESIGNATED FUNDS
All contributions made through the S.E.C.C.
SECC should be designated to a particular recipi-ent.
Any monies not designated to a particular
recipient shall be deemed as undesignated funds.
Undesignated funds shall be allocated by the
S.E.C.C. SECC to the oounty/ local S.E.C.C.
SECC committees. The oounty/ local S.E.C.C.
SECC shall distribute these funds within their
communities.
Statutory Authority G.S. 143-3.3; 143B-10.
.0407 .0307 EFFECTIVE DATE OF
8:12 NORTH CAROLINA REGISTER September 15, 1993 1013
PROPOSED RULES
AMENDED RULES
These amended rules shall become offootivo ao
gpooified by statute and ohall apply to all applioa
tions—then
—
pending—or thereafter approved be
effective for the 1994 SECC and thereafter .
Statutory Authority G.S. 143-3.3; 143B-10.
TITLE 10 - DEPARTMENT OF
HUMAN RESOURCES
l\otice is hereby given in accordance with G.S.
150B-21.2 that the Division of Facility Services
intends to adopt rules cited as 10 NCAC 3R .0214,
.1213- .1219, .1413- .1419,. 1619, .1720. .1912
- .1918. .2120, .2314 - .2320, .2713 - .2719.
.3101 -.3108, .3201 - .3207, .3301 -.3306, .3401
- .3407, .3501 - .3507, .3601 - .3607. .3701 -
.3707. .3801 - .3807, .3901 - .3908, .4001 -
.4012, .4101 - .4107; amend rules cited as 10
NCAC 3R .0304. .0309. .0321, .1613 - .1618,
.1713 - .1715. .1717 - .1719, .2113 - .2119; and
repeal rules cited as 10 NCAC 3R .1202 - . 1209,
. 1402. . 1404 - . 1409, .1716, . 1902, . 1904 - . 1908,
.2702- .2707, .2710- .2711.
1 he proposed effective date of this action is
January- 4, 1994.
1 he public hearing will be conducted at 10:00
a.m. on October 29, 1993 at the Council Building,
Room 201. 701 Barbour Drive, Raleigh, North
Carolina 27603.
Keason for Proposed Action:
10 NCAC 3R .1202 - .1209, .1213 - .1219, .1617
.1619, .1716, .1720, .2120, 4101 - .4107 -
Repeal existing "intensive care service", "open
heart surgical services" rules and adopt rules
which would incorporate current medical practices
and technologies. Amend existing and establish
criteria and standards for review of CON applica-tions
for Pediatric Intensive Care Services, Cardi-ac
Catheterization Services and Ambulatory Sur-gery
Services.
10 NCAC 3R .1614, .1615 - .1616, .2115, .2117,
.2118 - To adopt as permanent rules amendments
to the temporary rules adopted effective September
1 , 1993, which amend existing criteria and stan-dards
for Cardiac Catheterization Services and
Ambulatory Surgical Services.
10 NCAC 3R .0214, .2314 - .2320, .3101 - .3108,
.3201 - .3207, .3301 - .3306, .3401 - .3407, .3501
- .3507, .3601 - .3607, .3701 - .3707, .3801 -
.3807, .3901 - .3908, .4001 - .4012 - To adopt as
permanent rules the temporary rules adopted
effective September 1 , 1993, which amend existing
and establishes criteria and standards pursuant to
Senate Bill 10 which was ratified on March 18,
1993.
10 NCAC 3R .1402, .1404 - .1409, .1413 - .1419,
.1902, .1904 - .1908, .1912 - .1918, .2702 -
.2707, .2710 - .2711, .2713 - .2719 - To repeal
existing rules and adopt as permanent rules the
temporary rules adopted effective September 1,
1993 which establishes criteria and standards
pursuant to Senate Bill 10 which was ratified on
March 18, 1993.
10 NCAC 3R .0304, .0309, .0321, .1613, .1713
- .1715, .1717 - .1719, .2113 .2114, .2116,
.2119 - To adopt as permanent rules the temporary
rules adopted September 1, 1993 which amends
existing and establishes criteria and standards
pursuant to Senate Bill 10 which was ratified on
March 18, 1993.
i^omment Procedures: All written comments must
be submitted to Jackie Sheppard, APA Coordina-tor,
Division of Facility Services, P. O. Box
29530. Raleigh, NC 27626-0530. telephone (919)
733-2342, up to and including October 29, 1993.
Written comments submitted after the deadline will
not be considered.
Auditor's Note: Temporary rules have been filed
effective September 1, 1993 with the exception of
Rules 10 NCAC 3R .1202 - .1209, .1213 - .1219,
.1617 - .1619, .1716, .1720, .2120 and .4101 -
.4107. The text of the temporary rules may differ
from the proposed permanent rules published in
this notice. The temporary rules can be obtained
by contacting the Office of Administrative Hear-ings,
Rules Division at (919) 733-2678.
CHAPTER 3 - FACILITY SERVICES
SUBCHAPTER 3R - CERTIFICATE OF
NEED REGULATIONS
SECTION .0200 - EXEMPTIONS
.0214 REPLACEMENT EQUIPMENT
(a) The purpose of this Rule ]s to define the
terms used in the definition of "replacement
equipment" set forth in G.S. 131E-176(22a).
1014 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
(h) "Activities essential to acquiring and making
operational the replacement equipment" means
those activities which are indispensable and requi-site:
absent which the replacement equipment
could not be acquired or made operational.
(c) "Comparable medical equipment" means
equipment which is functionally similar and which
is used for the same diagnostic or treatment pur-poses.
(d) Replacement equipment is comparable to the
equipment being replaced if:
(1) il has the same basic technology as the
equipment currently in use, although it
may possess expanded capabilities due
to technological improvements; and
(2) it is functionally similar and is used for
the same diagnostic or treatment pur-poses
as the equipment currently in use
and is not used to provide a new health
service; and
(3) the acquisition of the equipment does
not result in more than a 10% increase
in patient charges or gsr procedure
operating expenses within the first
twelve months after the replacement
equipment is acquired; and
(4) it will be located on the same site or
campus as the equipment currently in
use.
(e) Replacement equipment is not comparable to
the equipment being replaced ifi
(1) the replacement equipment is new or
reconditioned, the existing equipment
was purchased second-hand, and the
replacement equipment is purchased
less than three years after the acquisi-tion
of the existing equipment; or
(2) the replacement equipment is new, the
existing equipment was reconditioned
when purchased, and the replacement
equipment is purchased less than three
years after the acquisition of the exist-ing
equipment; or
(3) the replacement equipment is perma-nently
fixed equipment and the existing
equipment is one piece of mobile equip-ment
which is shared between two or
more facilities.
(a) After receipt of a letter of intent, the agency
shall determine whether the proposed project
requires a certificate of need. In molcing this
deoiaion the agency shall consider th e obligation of
a capital expenditure on behalf of or for a health
service faoility to be :
(4^ an expenditure to bo obligated or in
ourred by the facility';
{3) an expenditure to be obligated or in
ourred by any person, board or organi
zation having ownership or control of
the faoility, or over which tho facility'
has ownership or control and which
relates to the provision of a hoalth
service;
0) an expenditure to bo obligated or in
ourred by any person, board or organi
zation with which the faoility has a
contractual relationship to provide or
purchase services, or share spaco, profit
or expenses—m—oonnootion—w4tfe—the
provision of a health service; or
(4) an expenditure to be obligated or in
ourred by any person, board or organi
zation developing a health service on
property owned or leased to or by the
faoility.
(b) If it is determined that the project requires a
certificate of need, the agency will determine the
appropriate review category or categories for the
proposed project, the type or types of application
forms to be submitted, the number of separate
applications to be submitted, the applicable review
period for each application, and the deadline date
for submitting each application.
(c) Copies of the application forms may be
obtained from the agency.
(d) Proposals requiring review will be reviewed
according to the categories and schedule set forth
in the duly adopted State Medical Facilities Plan in
effect at the time scheduled review period com-mences.
(e) Applications are competitive if they, in
whole or in part, are for the same or similar
services and the agency determines that the ap-proval
of one or more of the applications may
result in the denial of another application reviewed
in the same review period.
Statutory Authority G.S. 13] £-177(1). Statutory Authority G.S 131E-177; 131E-182.
SECTION .0300 - APPLICATION AND
REVIEW PROCESS
.0304 DETERMINATION OF REVIEW
.0309 REVIEW PERIOD
(a) The review of an application for a certificate
of need shall be completed within 90 days from the
beginning date of the review period for the appli-
8:12 NORTH CAROLINA REGISTER September 15, 1993 1015
PROPOSED RULES
cation, except as provided in Paragraph (b) of this
Rule.
(b) Except in the case of an expedited review,
Tb« the period for review may be extended for up
to 60 days by the agency if it determines that, for
one or more of the following reasons, it cannot
complete the review within 90 days:
(1) the extension is necessary to consider
conflicting, contradictory, or otherwise
relevant matters;
(2) the total number of applications
assigned to the project analyst for
review, including those in other review
periods, preclude the project analyst
from completing the review within 90
days;
(3) the complexity of the application or
applications to be reviewed make it
necessary to extend the review period;
(4) the review of an applicant's response to
the agency's request for additional
information has not been completed;
(5) the timing of the public hearing which
was held for the application or
applications under review does not
allow sufficient time to consider the
information presented;
(6) extension of previous reviews
necessitated that the project analyst
delay the commencement of the review;
or
(7) the unavailability of the project analyst
due to illness, annual leave, litigation
associated with other reviews, or other
duties and responsibilities.
(c) In the case of an expedited review, the
review period may be extended only if the Agency
has requested additional substantive information
from the applicant in accordance with G.S. 131E-
185(c).
(d) (e) Applicants will be provided written
notice of the extension of the review period after
the agency determines that an extension is
necessary. Failure to receive such notice prior to
the last day of the scheduled review period,
however, does not entitle an applicant to a
certificate of need nor authorize an applicant to
proceed with a project without one.
Statutory Authority G.S. 131E-177; 131E-185.
.0321 EXPEDITED REVIEW
(a) An applicant which desires an expedited
review shall submit a petition for an expedited
review with the Certificate of Need Section when
the application is submitted.
(b) The Certificate of Need Section shall review
the petition within 15 days from the beginning of
the review and shall notify the applicant if the
Agency has determined that a public hearing is in
the public interest.
(c) If the Certificate of Need Section decides
that it is not in the public interest to hold a public
hearing, a final determination on the request for an
expedited review shall not be issued until after the
thirty day written comment period has expired.
(dj If a request for a public hearing is received
by the Agency during the 30 day written comment
period, which is defined in G.S. 131E-185, the
request for an expedited review shall be denied.
(e) After the thirty day written comment period,
the Certificate of Need Section shall notify the
applicant that its petition for an expedited review
is approved or denied.
Statutory Authority G.S. 131E-177(1).
SECTION .1200 - CRITERIA AND
STANDARDS FOR INTENSIVE CARE
SERVICES
.1202 DEFINITIONS
TTie definitions in this Rule will apply to all rules
in this Section:
W- 4Ifntensive—eere those
—
services—means
sep.'ioes provided by an acute care caro
hospital te pati ents who require
continuous.—comprehensive
—
observation
and a high level of nursing core.
(3) "Intensive care unit" means a separate
self suffici ent—
e
ntity—within—which—aH-necessary
supplies and equipment
essential—te
—
provide
—
inte nsive—eare
services afe available—te pati e nts
requiring them.—This does not include
post op e rativ e r e covery rooms,
po s t delivery rooms. ef
—
emergency
observation unita.
Statutory Authority G.S 1 31 E- 177(1).
.1204 CAPACIT\ IN THE FACILITY AND
IN THE HEALTH SERVICE AREA
(e^
—
Proposals filed by or on behalf of hospital
faciliti es—fef
—
intensive—esfe
—
services—must—be
consistent with the applicable North Carolina State
Medical Facilities Plan, with th e applicabl e North
Carolina State Health Plan (the one in effect at
tifiw
of final—age ncy—decision)—aed—with—the
applicable h ealth systems plan.
1016 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
{b3 Propooalo—involving—new—ef
—
expanded
intonoivo oare bods must opeoif^' the numbero of
intensive oaro boda to bo operated following the
oompletion of the proposed project.
(e)
—
A proposal involving additional intensive
caro beds shall not be approved unless tho overall
as'omgo annual oooupanoy, over the
—
12 months
immediately—preceding—the
—
submittal—ef—the
proposal, of the total number of funotional existing
intensive oaro bods in the facility in which the
proposed beds are to bo operated i s at least 70
percent in unite with 20 or more intensive oare
bods, 65 percent in units with 10 19 intensive oare
bods, and 60 percent in units with 1 9 intensive
oare beds.
Statutory Authority G.S. 1 31 E- 177(1).
.1205 SCOPE OF SERVICES OFFERED
A proposal to provide new or expanded intensive
care services must document the extent to which
tho following will bo available.—If any item will
not be available, then substantive information must
bo given obviating tho need for that item before
approval for a nov'i ' or expanded service can be
given:
(4^ e
—
distinct,—identifiable—area—fef—the
provision of intensive care services ;
(S) twenty four hour on call availability of
laboratory and radiology services;
{i) 0;/air/suction capability;
(4) electronic cardiovascular monitoring
capability;
(§) capabilities for endotracheal intubation,
mechanical—ventilatory—assistance,—asd
oardiao pacemalcer insertion;
{6) oardiao arrest management plan;
f7) twenty four hour blood banlt.
Statutory Authority G.S. 131E-177(1).
.1206 PROJECTED UTILIZATION/
OCCUPANCY
(a)—A proposal to provide new or expanded
intensive care services must project an occupancy
level for the total intensive care services for each
of the first eight calendar quarters following the
oompletion of the proposed proj ect. An occupancy
level must also bo projected for each specialized
type of intensive care service to the extent that
specialized types of service are proposed to be
operated
.
—All assumptions, including the opooifio
methodologies by which occupancies are projected,
must be olearly stated.
•(b)
A proposal to provide new or expanded
intensive care services shall not be approved unless
oooupanoy is projected to be at least 75 percent for
the total number of intensive care beds proposed to
bo operated, no later than three years following the
oompletion—ef—the
—
proposed—project. AH
assumptions, including the specific methodologies
by
which—occupancies—are projected,—must—be
olearly stated.
(o) A proposal to establish a ne'.'. ' intensive oaro
or coronary oare unit shall not be approved unless
the utilization of tho unit is projected to be at least
at a rate of 4 b>eds at 75 percent occupancy no
later than throe years following the oompletion of
the proposed project.
Statutory Authority G.S. 131E-177(1).
.1207 PROJECTED PATIENT ORIGIN
(a)
—
A proposal to provide new or expanded
intensive care services must project patient origin
by
—
percentage—by
—
county—of residence. AH
assumptions, including the specific methodology
by whioh patient origin is projected, must be
clearly stated.
(b)
A proposal to provide new or expanded
intensive care services must show that at least 90
percent of the anticipated patient population is
within—45
—
minutes—automobile
—
driving—tiffle
(one way) from the facility, with the exception that
there
—
h*^"—be
—
variance
—
from—the—90
—
percent
standard for institutions traditionally offering very
specialized levels of intensive oare to a large and
geographically diverse population.
Statutory Authority G.S. 131E-177(1).
.1208 SITE AND EQUIPMENT
(a)
A proposal to provide new or expanded
intensive oare services must provide documentation
to shov/ that the services will be offered in a
phys ical—environment—that
—
conforms—te—the
requirements of federal, state, and local regulatory
bodies .
(fe)
A proposal to provide new or expanded
intensive care services must document the extent to
which—th«
following,—required—by—th«
—
Joint
Commiss ion on Accreditation of Hos pital s , will be
available.—If any item will not be available, then
substantive information must be given obviating
the need for that item before approval for a new or
expanded service can be given:
ft) oxygon—and
—
compressed—air and the
means of administration;
(3) mechanical ve ntilatory assistance
equipment—including airways,—manual
8:12 NORTH CAROLINA REGISTER September 15, 1993 1017
PROPOSED RULES
(^
breathing bag and ventilator/reopimtor;
oard i QO d e fibrillator with
synohronization capability;
(43 respiratory—afld
—
oardiao—monitoring
equipment;
(5^ thoranoentooio and closed thoroostomy
tmohoootomy sot;
toumiqucto;
f&3 vascular outdovvn oets;
(9) infusion pumps;
(+0) laryngoscopes and endotracheal tubes;
(44^ tracheobronchial—and
—
gastric—suction
equipment;
portable x my;
patient—weighing—device—fef—bed
patients.
Statutory Authority G.S. 131 £-177(1).
.1209 STAFFEVG
(e) A proposal—te
—
offer new—or expanded
intensive care services must provide documentation
to show that the appropriate t^'pes and numbers of
staff", particularly qualified medical and nursing
staff", will be available to support the services.
fb) A
—
proposal—te
offer—new—ef—
e
xpanded
intensive care services must provide documentation
to show that such services will be coordinated by
a registered nurse who—has formal training in
intensive care nursing.
Statutory Authority G.S 131 £-177(1).
.1213 DEFINITIONS
The definitions in this Rule shall apply to all
rules in this Section:
m "Intensive care services" means those
£2}
services provided by an acute care
hospital to patients with a wide variety of
illnesses of a life-threatening nature,
including patients with highly unstable
conditions which require so phisticated
medical and surgical intervention and a
high level of nursing care and those
patients which require continuous,
comprehensive observation.
"Intensive care unit" means a separate
self-sufficient entity which has all
supplies, equipment, and staff necessary
to offer intensive care services twenty-four
hours a day, seven days a week.
TTie term does not include post-operative
recovery rooms, post-delivery rooms, or
emergency observation units.
Statutory Authority G.S. 131 £-177(1).
.1214 INFORMATION REQUIRED OF
APPLICANT
(a) Applicant that proposes new or expanded
intensive care services shall use the Acute Care
Facility/Medical Equipment application form.
(b) Applicant proposing new or expanded inten-sive
care services shall also submit the following
additional information:
(1) the number of intensive care beds cur-rently
operated by the applicant and the
number of intensive care beds to be
operated following completion of the
proposed project;
(2) documentation of the applicant's experi-ence
in treating patients at the facility
during the past twelve months, includ-ing:
(A) the number of inpatient days of care
provided to intensive care patients;
(B) the number of patients initially treated
at the facility and referred to other
facilities for intensive care services;
and
(C) the number of patients initially treated
at other facilities and referred to the
applicant's facility for intensive care
services.
(3) the number of patients from the pro-posed
service area who are projected to
require intensive care services by the
patients' county of residence in each of
the first 12 quarters of operation, in-cluding
all assumptions and methodolo-gies;
(4) the projected number of patients to be
served and inpatient days of care to be
provided by county of residence by
specialized type of intensive care for
each of the first twelve calendar quar-ters
following completion of the pro-posed
project, including all assumptions
and methodologies;
(5) correspondence from the proposed
referral sources documenting their
intent to refer patients to the applicant's
facility;
(6) documentation which demonstrates the
applicant's capability to communicate
effectively with emergency transporta-tion
agencies,
(7) documentation of written policies and
procedures regarding the provision of
care within the intensive care unit.
1018 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
which includes, but js riot limited to the
following:
(A) the admission and discharge of pa-tients:
(B) infection control: and
(C) safety procedures;
(8) documentation that the proposed service
shall be operated in an area organized
as a physically and functionally distinct
entity, separate from the rest of the
facility, with controlled access;
(9) documentation to show that the services
shall be offered in a physical environ-ment
that conforms to the requirements
of federal, state, and local regulatory
bodies:
(10) a detailed floor plan of the proposed
area drawn to scale: and
(1 1) documentation of a means for observa-tion
by unit stafF of alj patients ]n the
unit from one vantage point.
Statutory Authority G.S. 131E-177(1}.
.1215 REQUIRED PERFORMANCE
STANDARDS
The applicant shall demonstrate that the proposed
project is capable of meeting the following stan-dards:
(1) the overall average annual occupancy rate
of all intensive care beds in the facility,
excluding neonatal and pediatric intensive
care beds, over the 12 months immediate-ly
preceding the submittal of the propos-al,
shall have been at least 70 percent for
facilities with 20 or more intensive care
beds, 65 percent for facilities with 10-19
intensive care beds, and 60 percent for
facilities with 1-9 intensive care beds;
(2) the projected occupancy rate for all inten-sive
care beds in the applicant's facility,
exclusive of neonatal and pediatric inten-sive
care beds, shall be at least 70 per-cent
for facilities with 20 or more inten-sive
care beds, 65 percent for facilities
with 10-19 intensive care beds, and 60
percent for facilities with 1-9 intensive
care beds, in the third operating year
following the completion of the proposed
project; and
(3) all assumptions and data supporting the
methodology by which the occupancy
rates are projected shall be provided.
Statutory Authority G.S. 131E-177(1).
.1216 REQUIRED SUPPORT SERVICES
(a) An applicant proposing new or additional
intensive care services shall document the extent to
which the following items are available:
(1) twenty-four hour on-call laboratory
services including microspecimen chem-istry
techniques and blood gas determi-nations;
(2) twenty-four hour on-call radiology
services, including portable radiological
equipment;
(3) twenty-four hour blood bank services:
(4) twenty-four hour on-call pharmacy
15} twenty-four hour on-call coverage by
respiratory therapy:
oxygen and air and suction capability;
electronic cardiovascular monitoring
capability:
mechanical ventilatory assistance equip-ment
including airways, manual breath-ing
bag and ventilator/respirator:
endotracheal intubation capability:
cardiac pacemaker insertion capability;
cardiac arrest management plan;
patient weighing device for bed
patients; and
isolation capability,
(b) If any item in Subparagraphs (a)(1) - (13) of
this Rule will not be available, the applicant shall
document the reason why the item is not needed
(61 m
18}
19}
(10)
ILQ
(12)
(13)
for the provision of the proposed services.
Statutory Authority G.S. 131E-177(1).
.1217 REQUIRED STAFFING AND STAFF
TRAINING
The applicant shall demonstrate the ability to
meet the following staffing requirements, in
accordance with recommendations and standards
from the Society of Critical Care Medicine for
intensive care units:
(1) nursing care shall be supervised by a
qualified registered nurse with specialized
training in the care of critically ill
patients, cardiovascular monitoring, and
life support;
(2) direction of the unit shall be provided by
a physician with training, experience and
expertise in critical care;
£3} assurance from the medical staff" that
twenty-four hour medical and surgical
on-call coverage is available: and
(4) appropriate inservice training or
continuing education programs shall be
8.12 NORTH CAROLINA REGISTER September 15, 1993 1019
PROPOSED RULES
provided for the intensive care staff.
Statutory Authority G.S. 131 £-177(1).
.1218 ACCESSIBILITY
(a) The applicant shall provide documentation
describing the mechanism that will be used to
insure that the projected number of medically
underserved will be served in the facility.
(b) The applicant shall provide written
admissions policies identifying any prepayment or
deposit requirements for the facility and
specifically stating the admission requirements for
patients in each of the following payor categories:
(1) Medicare;
(2) Medicaid;
(3) Blue Cross and Blue Shield;
(4) Commercial Insurance;
(5) State Employees Health Plan;
(6) Self-Pay (includes self-pay, indigent
and charity care); and
(7) Other as identified by the applicant.
(c) The applicant shall provide a written
description of the billing procedures, including the
credit and collection policies that will be utilized
by the facility.
(d) The applicant shall document that the health
care community in the service area, including the
Departments of Social Services and Health, have
been invited to comment on the proposed project,
particularly with regard to the facility's referral
mechanisms and admissions policies for the
medically underserved.
Statutory Authority G.S 131E-177(1).
.1219 DATA REPORTING REQUIREMENTS
The facility shall agree to provide, upon the
request of the Division of Facility Services, the
following types of data and information, in
accordance with data format and reporting
requirements formulated by the Division of
Facility Services:
(1) demographic data on patients treated;
(2) financial data; and
(3) clinical data.
Statutory Authority G.S. 131 £-177(1).
SECTION .1400 - CRITERIA AND
STANDARDS FOR NEONATAL SERVICES
.1402 DEFINITIONS
The definitions in this Rule will apply to all rules
in this Section:
(4^ "Normal newborn ocrvicoo" mcano those
routine Bervioes—provided by an acute
oare hospital to—normal fiill term -asd
normal pre term infante weighing at loost
2000 grams at birth. Routine oaro within
th+fi context includes increased
observation, screening, and otabilization
e#
—
infants—within—tbe—fi«t
—
ieuf—te
twenty four hours following birth.
"Neonatal—continuing—eaf=e
(3)- services"
m-means—
those—services—provided—by—aa
acute care hospital to low birth weight
infants who are not sick but who require
frequent feeding, infants who no longer
require neonatal intermediate eare
services—fetrt—wbe—stiH
—
require more
nursing hours than normal infants, and
infants who require close obsop>'ation for
any reason.
"Neonatal—intermediate—eafe
—
s ervices"
means those services—provided by an
acute care hospital to siok infants who do
not require neonatal intensive care but
who do—require six to twelve nursing
hours per day.
"Neonatal intensive care services" means
those services provided by an acute care
hospital—te
—
severely—iH
—
infants—wbe
require constant nursing care, as well as
continuous cardiopulmonary and other
supportive care.—Neonatal intensive care
difFers from neonatal intermediate care
with
—
regard—te—the
—
complexity'—&e
multiplicity' of patient problems, e.g. care
required for neonatal surgery' patients.
"Neonatal services"—means any of the
services defined in this Rule.
{4^
{§)-
Statutory Authority G. S 131E-1 77(1).
.1404 CAPACITY E^J THE FACILITY AND
ESf THE HEALTH SERVICE AREA
4a)
—
Proposals filed by or on behalf of hospital
facilities for neonatal services must be consiste nt
with the applicable North Carolina State Medical
Facilities Plan, with th e applicable North Carolina
State Health Plan (the one in effect at time of final
agency decision), and with the applicable health
systems plan.
{b) Proposals—involving—new
er—
e
xpanded
neonatal bassinets/beds must specify' the numbers
of neonatal bassinets/beds to be operated following
the completion of the proposed proj ect. Such
specification must be in terms of normal newborn
services.—neonatal—continuing—eafe
—
services.
1020 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
neonatal intermodiate ooro oorvioes, and neonatal
intonoivo oaro oorvioes. If lovela of oare other than
tbat—fep
—
normal—newborns—afe
—
involved,—tbe
proponont must define tho manner in whioh the
proponent deoignatoo beds for auoh lovelo.
•(e)
—
A proposal involving a net inoreose in the
tetal
number—of a—faoility's—existing—neonatal
intermediate oare beds and neonatal intensive oare
beds shall not be approved unless the overall
average annual oooupanoy,—over the
—
12 months
immediately—preceding—the
—
submittal—ef—the
proposal,—ef—th«
—
functional—existing—neonatal
intermediate care beds in the facility in whioh the
proposed beds are to bo operated is at least 8
percent.
4d) He—proposal—fer
—
additional—neonatal
intermediate care or neonatal intensive care beds
shall be approved unless it is determined that an
unmet need exists in the health service area or in
the proponent's defined service area in whioh the
proposed beds are to be operated. Need for
neonatal—intermediate—eare—beds—asd
—
neonatal
intensive care beds shall be computed for each of
the six established health service areas in North
Carolina by:
(4-) identifying the annual number of live
births occurring at all hospitals located
within the health service area, using the
latest available data compiled by the
Division of Health Services;
(3) identifying th e low birth weight rate
(percent—of live—births—below—2500
grams) for the births identified in (1) of
tbis
—
Subparagraph,—using—the
—
latest
available data compil ed by the Division
of Health Services;
f^ dividing—the—lew—bifth
—
weight—Fate
identified in (2) of this Subparagraph by
.08 and subsequently multiplying the
resulting quotient by four; and
{4) determining need for neonatal intensive
©are—beds—aed
—
neonatal—intermediate
oare beds in the h ealth service area as
the product of:
(A)
—
the product derived in—(3) of this
m-
Subparagraph, and
-the
—
quotient—resulting from—the
division of the number of live births
in the initial year of the projection
identified in (1) of this Subparagraph
by the number 1000.
Statutory Authority G.S. 131E-177(1).
.1405 SCOPE OF SERVICES OFFERED
{a)
—
A proposal to provide new normal newborn
services or neonatal continuing care services must
document the extent to which the following Vr'ill be
available.—If any item will not be available, then
substantive information must be given obviating
tho need for that item before appro^'al for a new or
expanded service can be given:
<4^ a
distinct,—identifiable—area
—
for tho
provision of the proposed service;
43) competence to manage uncomplicated
labor—asd
—
delivery—ef
—
normal—term
newborn;
4^) capability fef continuous fetal
monitoring;
(4) a
—
continuing—
e
ducation—program—ee
resuscitation—te
—
enhance—competence
among all delivery room personnel in
tb« immediate evaluation aft4
resuscitation of the newborn and of tho
mother;
(#) availability of obstetric services;
{6) capability for cesarean section within 30
minutes at any hour; and
f?) twenty four hour on call availability of
blood,—anesthesia—service,—radiology
service, clinical laboratory service.
(b)
—
A proposal to provide new or expanded
neonatal intermediate care services or neonatal
intensive care services must meet the requirements
of (a) of this Rule as well as document the extent
to whioh the following will be available.—If any
itofH—wiH—net—be
—
available,—then—
s
ubstantive
information must be given obviating the need for
that item before approval for a new or expanded
service can be given:
-a
k^ distinct,—identifiable—area—for—the
provision of th e proposed sorvioo;
{3) competence—te
—
manage
—
labor—and
delivery of premature newborns and
newborns with complications;
{5) twenty four hour coverage »f
microchemistry hematology and blood
gases;
f4) twenty four hour coverage by
respiratory therapy;
{5) twenty four hour coverage with
portable radiographic capability;
-Q;/air/suction capability';
6^ e lectronic cardiovascular ft»d
respiration monitoring capability;
48)- capabilities for endotracheal intubation
and meohanical ventilator^' assistance ;
oardio respirator^'—arrest—management
plan.
8:12 NORTH CAROLINA REGISTER September 15, 1993 1021
PROPOSED RULES
Statutory Authority G.S. 131E-177(1).
.1406 PROJECTED UTILIZATION/
OCCUPANCY
(a)
ProponentB proposing new normal newborn
and neonatal continuing oare oervioes must per
form, or projeot to perform, at looot 500 deliver
ioo, per year except that a varianoo from this
standard will be allowed to the extent that a sub
stantial portion of the population to be served
reside more than 45 minutes automobile driving
time (one vipy) from existing inpatient noonatol
servioeo.
{b)
A proposal to provide new normal newborn
or neonatal continuing oare oervioes. or new or
expanded interm ediate care oervioes or neonatal
intensive oare services , or any combination of the
four muot projeot an ocoupanoy level for each of
the services for each of the first eight calendar
quartero following the completion of the propooed
projeot.—All assumptions, including the speoifio
methodologies by whioh oooupancies are projected,
must be clearly stated.
{&)—A proposal to provide new normal newborn
and neonatal continuing care oervioes shall not be
approved—unless—for the total—number of beds
proposed to—be operated annual—occupancy—ts
projected to be 50 percent. Occupancy i o proj ected
to be 60 percent for a 1 10 bed unit, 65 percent
for a 11 20 bed unit. 70 percent for a 21 30 bed
unit, and 75 percent for a unit of 31 beds or more
after two years foUowmg the completion of the
proposed project.—All assumptions, including the
speoifio methodologies by whioh occupancies are
projected, must be clearly stated.
fd)
—
A proposal to provide new neonatal inter
mediate care services or new neonatal intensive
care services shall not be approved unless ocou
panoy is projected to be at least 75 percent for the
total number of neonatal intermediate care beds
and neonatal intensive oare beds proposed to be
operated, no later than three years following th e
completion of the propo sed projects.—All assump
tions,—mcluding—the specific—methodologi es—by
which occupancies are projected, must be clearly
stated
.
Statutory Authority G.S 131 E-1 77(1).
service by poroontage by oounty of residonoo.—AH
assumptions, including the speoifio methodology
by which patient origin is projootod.—must be
olearly stated.
{b)
—
A proposal to provide now normal newborn
or neonatal continuing care services must doou
ment that at least 90 percent of the anticipated
patient population is within 45 minutes driving
time (one way) from th e facility.
(e)
—
A proposal to provide now or expanded
neonatal—intermediate oare sorvioos—or new or
expanded neonatal—intensive care servicoo—mus t
document that at least 90 percent of tho anticipated
patient population is within 90 minutes driving
time (one v.oy) from the facility', with tho oxcop
tion that there may be a variance from the 90
percent standard for institutions with very special
ized levels of neonatal care to a largo and goo
graphically diverse population.
Statutory Authority G.S 131E-1 77(1).
.1408 SITE AND EQUIPMENT
A proposal to provide new or expanded neonatal
services must provide documentation to show that
the services will be ofiFered in a physical environ
ment that conforms to the requirement!) of federal,
state, and local regulator^' bodies.
Statutory Authority G.S 131E-177(1).
.1409 STAFFING
(a) A proposal to offer new or expanded ncona
tal services must provide documentation to show
that the appropriate types and numbers of staff,
particularly qualified medical and nursing staff",
will be available to support the servicoo.
{b)—A proposal to off^er new or expanded neona
tal intermediate care or neonatal intensive care
services must provide documentation to show that
such services will:
^4^ be coordinated by a registered nurse
who has completed an organized eduoa
tional program in neonatal intermediate
and intens ive care, and
(3) be under the direction of a physician
with training and experience in neonatal
intermediate and intensive care.
.1407 PROJECTED PATIENT ORIGIN
(a)
—
A proposal to provide new normal newborn
or neonatal continuing care services, or new or
expanded intermediate care services or neonatal
intensive care services, or any combination of th e
four must project patient origin for each proposed
Statutory Authority G.S 131 E-1 77(1).
.1413 DEFINITIONS
The definitions in this Rule shall apply to all
rules in this Section:
( 1) "Approved neonatal service" means a
1022 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
I2i
i21
14}
15}
neonatal service that was not operational
prior to the beginning of the review
period but that had been issued a
certificate of need or for which
development had been initiated prior to
March 18. 1993 in accordance with G.S.
131E-175. et. al.
"Existing neonatal service" means a
16}
neonatal service in operation prior to the
beginning of the review period.
"High-risk obstetric patients" means
those patients requiring specialized
services provided by an acute care
hospital to the mother and fetus during
pregnancy, labor, delivery and to the
mother after delivery. The services are
characterized by specialized facilities and
staff for the intensive care and
management of high-risk maternal and
fetal patients before and during delivery.
"Level I neonatal service" means those
routine services provided by an acute
care hospital to normal full -term and pre-term
infants weighing at least 2000 grams
at birth. Level I neonatal services
include the observation, screening, and
stabilization of: infants following birth
who are served in a bassinet; infants who
are not sick but who require special care
and frequent feedings; infants who no
longer require Level II or Level III
neonatal services, but who still require
more nursing hours than normal infants;
and infants who require close observation
in a licensed acute care bed.
"Level II neonatal service" means the
performance of Level I neonatal services,
plus the management of high-risk, small,
and sick neonates with a moderate degree
of illness that are admitted within the
hospital or transferred from another
facility. Level II neonatal services
involve the management of newborns
weighing between approximately 1,500-
2,500 grams (or approximately 32 and
less than 36 completed weeks of
gestational age) that are relatively
healthy, or involve intermediate care
services for sick infants who do not
require intensive care but who do require
six to twelve nursing hours per day.
Level II neonatal services are provided in
a licensed acute care bed.
"Level III neonatal service" means the
performance of Level I and Level U
m
£8}
£9}
(10)
neonatal services plus the management of
high-risk newborns weighing less than
1,500 grams (or approximately under 32
weeks of gestational age), which requires
neonatal expertise. Level III neonates
require constant nursing care, including
but not limited to continuous
cardiopulmonary and other supportive
care, care required for neonatal surgery
patients and other intensive care services.
Level III neonatal services are provided
in a licensed acute care bed.
"Neonatal intensive care services" is
defined in G.S. I31E-I76(15b).
"Neonatal service area" means a
geographic area defined by the applicant
from which the patients to be admitted to
the service will originate.
"Neonatal services" means any of the
Level L Level II or Level III services
defined in this Rule.
"Obstetric services" means any normal or
high-risk services provided by an acute
care hospital to the mother and fetus
during pregnancy, labor, delivery and to
the mother after delivery.
"Perinatal services" means services
provided during the period shortly before
and after birth.
"Perinatal regions" mean a geographic
area of the state as established by the
Perinatal Council. A copy of the
perinatal regions may be obtained from
the Division of Maternal and Child
Health, Department of Environment,
Health and Natural Resources, 1330 St.
Mary's Street, Raleigh. NC. 27605-3248.
Statutory Authority G.S. 131E-177(1).
.1414 INFORMATION REQUIRED OF
APPLICANT
(a) An applicant proposing to develop a new
neonatal service or to add a bed to an existing
neonatal service shall use the Acute Care
Facility/Medical Equipment application form.
(b) The applicant shall provide the following
additional information:
(1
)
the current number of Level I bassinets.
Level I beds. Level H beds and Level
III beds operated by the applicant;
(2) the proposed number of Level I
bassinets. Level I beds. Level H beds
and Level III beds to be operated
following completion of the proposed
nil
12}
8:12 NORTH CAROLINA REGISTER September 15, 1993 1023
PROPOSED RULES
project;
(3) evidence of the applicant's experience
in treating the following patients at the
facility during the past twelve months,
including:
(A) the number of obstetrical patients
treated at the acute care facility;
(B) the number of neonatal patients
treated in Level I bassinets. Level I
beds. Level II beds and Level III
beds, respectively;
(C) the number of inpatient days at the
facility provided to obstetrical
patients;
(D) the number of inpatient days provided
in Level I beds. Level U beds and
Level III beds, respectively;
(E) the number of high-nsk obstetrical
patients treated at the applicant's
facility and the number of high-risk
obstetrical patients referred from the
applicant's facility to other facilities
or programs; and
(F) the number of neonatal patients
referred to other facilities for
services, identified by required level
of neonatal service (i.e. Level ]_,
Level II or Level III);
(4) the projected number of neonatal
patients to be served identified by Level
L Level II and Level III neonatal
services and by county of residence for
each of the first twelve quarters of
operation following the completion of
the project, including the methodology
and assumptions used for the
projections;
(5) the projected utilization of the Level I
bassinets. Level I beds. Level H beds
and Level III beds, respectively, by
county of residence for each of the first
twelve quarters of operation following
completion of the project, including the
methodology and assumptions used for
the projections;
(6) if proposing to provide Level I neonatal
services, documentation that at least 90
percent of the anticipated patient
population is within 45 minutes driving
time one-way from the facility;
(7) if proposing to provide Level ] neonatal
services, documentation of a written
plan to transport infants to Level II or
Level III neonatal services as the
infant's care re<quires;
181
19}
(10)
an
12)
if proposing to provide Level U or
Level III neonatal services,
documentation that at least 90 percent
of the anticipated patient population is
within 90 minutes driving time one-way
from the facility, with the exception
that there shall be a variance from the
90 percent standard for facilities which
demonstrate that they provide very
specialized levels of neonatal care to a
large and geographically diverse
population, or facilities which
demonstrate the availability of air
ambulance services for neonatal
patients;
evidence that existing and approved
neonatal services and obstetric services
in the applicant's perinatal region and
in the applicant's defined neonatal
service area are unable to accommodate
the applicant's projected need
additional Level I] and Level
services;
for
III
IB)
IQ
ID]
ID
IF]
(13)
documentation of the availability of
existing obstetric services, and the
identification of ajj obstetrics programs
and neonatal services which currently
serve patients from the applicant's
primary service area;
an analysis of the proposal's impact
upon existing and approved neonatal
services in the same perinatal region(s)
and those perinatal regions adjacent to
the perinatal region(s) in which the
applicant proposes to provide services,
including but not limited to the
proposal's effect on the utilization of
existing neonatal services, except when
an applicant demonstrates that they
provide very specialized levels of
neonatal care to a large and
geographically diverse population;
evidence that the applicant shall have
access to a transport service with at
least the following components:
trained personnel;
transport incubator;
emergency resuscitation equipment;
oxygen supply and the means of
administration;
portable cardiac and temperature
monitors; and
a ventilator;
documentation that the new or
additional neonatal service shall be
1024 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
iM
£B}
im
£F}
(14)
coordinated with the existing statewide
perinatal network, including but not
limited to:
the Division of Maternal and Child
Health of the Department of
Environment, Health and Natural
Resources,
the physicians' statewide neonatal bed
locator system,
existing neonatal services,
existing obstetrical services,
home health care agencies,
other hospitals, and
local Departments of Social Services;
copies of written policies which provide
for parental participation in the care of
their infant, as the infant's condition
family
care
(15)
permits, in order to facilitate
adjustment and continuity of
following discharge: and
copies of written policies and
£A}
Hi
ID}
{c} An
additional
following: m
oi
m
141
(51
procedures regarding the scope and
provision of care within the neonatal
service, including but not limited to the
following:
the admission and discharge of
patients;
infection control;
pertinent safety practices; and
the triaging of patients requiring
consultations, including the transfer of
patients to another facility,
applicant proposing to provide new or
neonatal services shall provide the
documentation that the proposed service
shall be operated in an area organized
as a physically and functionally distinct
entity with controlled access;
documentation to show that the new or
additional Level I^ Level II or Level III
neonatal services shall be offered in a
physical environment that conforms to
the requirements of federal , state, and
local regulatory bodies;
a detailed floor plan of the proposed
area drawn to scale;
documentation of direct or indirect
visual observation by unit staff of all
patients from one or more vantage
points; and
documentation that the floor space
allocated to each bed and bassinet shall
accommodate equipment and personnel
to meet anticipated contingencies.
Statutory Authority G.S. ] 31 E- 177(1).
.1415 REQUIRED PERFORMANCE
STANDARDS
(a) An applicant shall demonstrate that the
proposed project is capable of meeting the
following standards:
(1) applicants proposing new or additional
Level I services shall perform or
project to perform, at least 500
deliveries per year, except that a
variance from this stendard shall be
allowed to the extent that a major
portion of the population to be served
reside more than 45 minutes automobile
driving time one-way from existing
inpatient neonatal services;
(2) applicants proposing new or additional
Level I services shall demonstrate that
the following standards will be met:
(A) the occupancy of the applicant's tofal
number of neonatal beds is projected
to be 50% or more during the first
year of operation following
completion of the proposed project-
Provide all assumptions and data
supporting the methodology used for
the projections;
(B) if an applicant is proposing additional
Level I services and does not
currently provide Level II or Level III
services, the projected occupancy of
the proposed service shall be at least
75% after the second year of
operation following completion of the
proposed project and provide all
assumptions and data supporting the
methodology used for the projections;
(C) if an applicant is proposing additional
Level I services and currently
provides Level II or Level III
services, the projected occupancy of
all neonatal services in the facility
shall be at least 65% after the second
year of operation following
completion of the proposed project,
and provide all assumptions and data
supporting the methodology used for
the projections;
the total number of Level I neonatal
bassinets and Level I neonatal beds
projected to be operated in the facility
shall exceed the number of obstetric
beds in the facility by at least 25%;
and
£D}
8:12 NORTH CAROLINA REGISTER September 15, 1993 1025
PROPOSED RULES
lEi
ill
(4)
the total number of Level I neonatal
bassinets and Level I neonatal beds
projected to be operated in the facility
shall exceed the number of obstetric
beds in the facility by at least 35% if
Level n or Level 111 services will be
provided in the facility;
if an applicant proposes an increase in
the number of the facility's existing
Level II or Level III beds, the overall
average annual occupancy of the total
number of existing Level II and Level
III beds in the facility is at least 75%.
over the \2 months immediately
preceding the submitfal of the proposal;
and
if an applicant is proposing to develop
a new or additional Level II or Level
III beds, the projected occupancy of the
total number of Level II and Level III
beds proposed to be operated after the
second year of operation of the
proposed project shall be at least 75%.
The applicant shall document the
assumptions and provide data
supporting the methodology used for
the projections.
(b) If an applicant proposes to develop a new
Level II or Level III service the applicant shall
document that an unmet need exists in the perinatal
region or in the applicant's defined neonatal
service area. The need for Level II and Level III
beds shall be computed for each of the perinatal
regions in North Carolina or in the applicant's
neonatal service area by:
(1) identifying the annual number of live
births occurring at all. hospitals within
the perinatal region or proposed
neonatal service area, using the latest
available data compiled by the State
Center for Health and Environmental
Statistics;
(2) identifying the low birth weight rate
(percent of live births below 2.500
grams) for the births identified in £1J of
this Paragraph. using the latest
available date compiled by the State
Center for Health and Environmental
Statistics;
(3) dividing the low birth weight rate
identified in (2) of this Paragraph by
08 and subsequently multiplying the
resulting quotient by four; and
(4) determining the need for Level II and
Level III beds m the perinatal region or
proposed neonatal service area as the
product of:
(A) the product derived in £3) of this
Paragraph, and
(B) the quotient resulting from the
division of the number of live births
in the initial year of the determination
identified in OJ of this Paragraph by
the number 1000.
Statutory Authority G.S. 131E-177(1).
.1416 REQUIRED SUPPORT SERVICES
(a) An applicant proposing to provide new or
additional Level f. Level II or Level III services
shall document that the following items shall be
available, unless an item shall not be available,
then documentation shall be provided obviating the
need for that item:
m
121
ID
competence to manage uncomplicated
labor and delivery of normal term
newborn;
capability for continuous fetal
monitoring;
a continuing education program on
resuscitation to enhance competence
among all delivery room personnel in
the immediate evaluation and
resuscitation of the newborn and of the
mother;
obstetric services;
anesthesia services;
capability of cesarean section within 30
minutes at any hour of the day; and
twenty-four hour on-call blood bank,
radiology, and clinical laboratory
services.
(b) An applicant proposing to provide new or
additional Level II or Level III services shall
document that the following items shall be
available, unless any item shall not be available,
then documentation shall be provided obviating the
need for that item:
labor
£41
(5)
(6)
ill
12}
£3}
14]
15}
£6}
competence to manage and
delivery of premature newborns and
newborns with complications;
twenty-four hour availability of
microchemistry hematology and blood
gases;
twenty-four hour coverage by
respiratory therapy;
twenty-four hour radiology coverage
with portable radiographic capability;
oxygen and air and suction capability;
electronic cardiovascular and
1026 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
respiration monitoring capability;
(7) vital sign monitoring equipment which
has an alarm system that is operative at
all times;
(8) capabilities for endotracheal intubation
and mechanical ventilatory assistance;
£9} cardio-respiratory arrest management
plan;
(10) isolation capabilities;
(11) social services staff;
(12) occupational or physical therapies with
neonatal expertise; and
(13) a registered dietician or nutritionist with
training to meet the special needs of
neonates.
(c) An applicant proposing to provide new or
additional Level III services shall document that
the following items shall be available, unless any
item shall not be available, then documentation
shall be provided obviating the need for that item:
(1) pediatric surgery services;
ophthalmology services;
pediatric neurology services;
pediatric cardiology services;
on-site laboratory facilities;
computed tomography and pediatric
cardiac catheterization services;
emergency diagnostic studies available
24 hours per day;
designated social services staff; and
serve as a resource center for the
13}
£41
15}
£6}
01
(81
19}
statewide perinatal network.
Statutory Authority G.S. 131E-177(1).
.1417 REQUIRED STAFFING AND STAFF
TRAINING
An applicant shall demonstrate that the following
staffing requirements for hospital care of newborn
infants shall be met:
(1) If proposing to provide new or additional
Level I services the applicant shall
provide documentation to demonstrate
that:
(a) the nursing care shall be supervised by
a registered nurse in charge of perinatal
facilities;
(b) a physician is designated to be responsi-ble
for neonatal care; and
(c) the medical staff will provide physician
coverage to meet the specific needs of
patients on a 24 hour basis.
(2) If proposing to provide new or additional
Level II services the applicant shall pro-vide
documentation to demonstrate that:
(a) the nursing care shall be supervised by
a registered nurse with educational
preparation and advanced skills for
maternal-fetal and neonatal services;
(b) the service shall be stafFed by a board
certified pediatrician with certification,
special interest, experience, or training
in neonatology; and
(c) the medical staff will provide physician
coverage to meet the specific needs of
patients on a 24 hour basis.
(3) If proposing to provide new or additional
Level III services the applicant shall
provide documentation to demonstrate
that:
(a) the nursing care shall be supervised by
a registered nurse with educational
preparation and advanced skills for
maternal-fetal and neonatal services;
(b) the service shall be staffed by a full-time
board certified pediatrician with
certification in neonatal medicine; and
(c) the medical staff will provide physician
coverage to meet the specific needs of
patients on a 24 hour basis.
(4) All applicants shall submit documentation
which demonstrates the availability of
appropriate inservice training or continu-ing
education programs for neonatal staff.
(5) All applicants shall submit documentation
which demonstrates the proficiency and
ability of the nursing staff in teaching
parents how to care for neonatal patients
following discharge to home.
(6) All applicants shall submit documentation
to show that the proposed neonatal ser-vices
will be provided fn conformance
with the requirements of federal . state
and local regulatory bodies.
Statutory Authority G.S. 131E-]77(1).
.1418 DATA REPORTING REQUIREMENTS
The facility shall agree to provide, upon the
request of the Division of Facility Services, the
following types of data and information, m accor-dance
with data format and reporting requirements
formulated by the Division of Facility Services:
(1) demographic data on patients treated;
(2) financial data; and
(3) clinical data.
Statutory Authority G.S 131E-177(1).
.1419 ACCESSIBILITY
8:12 NORTH CAROLINA REGISTER September 15, 1993 1027
PROPOSED RULES
(a) The applicant shall provide documentation
describing the mechanism that shall be used to
insure that the projected number of medically
underserved shall be served in the unit.
(b) The applicant shall provide a copy of the
written admissions policies identifying any prepay-ment
or deposit requirements for the facility and
stating the admissions requirements for each of the
following payor categories:
m
121
£3}
14]
15)
(6}
Medicare;
Medicaid;
Blue Cross and Blue Shield;
Commercial Insurance;
indigent
17}
State Employees Health Plan;
Self-Pay (includes self-pay,
and charity care) ; and
Other as identified by the applicant.
(c) The applicant shall provide a written descrip-tion
of the billing procedures, including the credit
collection policies, that shall be utilized by the
facility.
(d) The applicant shall document that the health
care community in the applicants neonatal service
area, including the Departments of Social Services
and Health, have been invited to comment on the
proposed project, particularly with regard to the
facility's referral mechanisms and admissions
policies for the medically underserved.
Statutory Authority G.S. 1 31 E- 1 77(1).
SECTION .1600 - CRITERIA AND
STANDARDS FOR CARDIAC
CATHETERIZATION EQUIPMENT AND
CARDIAC ANGIOPLASTY EQUIPMENT
.1613 DEFINITIONS
The following definitions wiH shall apply to all
rules in this Section:
(1) "Approved" means the equipment was
not in operation prior to the beginning of
the review period and had been issued a
certificate of need or had been acquired
prior to March 18, 1993 in accordance
with G.S.I3IE-175, et. al.
(2) fB "Capacity" of a an item of cardiac
catheterization room equipment or cardi-ac
angioplasty equipment is considered to
be lOOQ means 1270 diagnostic-equiva-lent
procedures per year. One PTCA
therapeutic cardiac catheterization proce-dure
is valued at twe 1 .67 diagnostic-equivalent
procedures. One pediatric
cardiac catheterization procedure per-formed
on a patient age five or under is
valued at two diagnostic-equivalent pro-cedures.
All other procedures are valued
at one diagnostic-equivalent procedure.
(3) "Cardiac angioplasty equipment" is de-fined
in G.S.131E-176(2e).
(4) (3) "Cardiac catheterization" is means a
diagnostic, electrophysiology or therapeu-tic
procedure performed using cardiac
catheterization equipment or cardiac
angioplasty equipment in a cardiac cathe-terization
room, whereby a flexible tube
is inserted into the patient's body , usually
through an extremity blood veoael, and
advanced under—fluorosoopio—guidance
into the heart chambers to perform a
hemodynamic or angiographic examina-tion
or therapeutic intervention of the left
and or right heart chamber, or coronary
arteries-;
—
therapeutic—intervention—m—
a
coronary artery' may also be performed
using oardiao catheterization. By thi s
definition a cardiac catheterization procc
dure does not include a simpl e right heart
catheterization for monitoring purposes as
might bo done in an electrophysiology
laboratory, pulmonary angiography as an
isolated—procedure,—&f—cardiac—pacing
through a right e l ectrode catheter. k
does include angiographic procedures to
evaluate the coronary' arteries, and aortic
root injections to examine the degree of
aortic regurgitation or deformity of aortic
valve .
(5) "Cardiac catheterization equipment" is
defined in G.S. 131E-176(2f).
(6) (^ "Cardiac catheterization procedure"
means a single episode of diagnostic,
electrophysiology or therapeutic catheter-ization
which occurs during one visit to a
cardiac catheterization room.
(7) (4) "Cardiac catheterization room" means
a room in a hospital or a mobile unit in
which has the there is cardiac catheteriza-tion
or cardiac angioplasty equipment
required—te
—
perform—angiographic—and
phys iologic for the provision of cardiac
catheterization procedures , and which has
been approved by th e Certificate of Need
Section as a cardiac catheterization room
services .
(8) fl-B
" Cardiac catheterization Sservice
area" means a geographical area defined
by the proponent applicant , which has
boundaries that are not farther than 90
road miles from the facility, if the facility
1028 8:12 NORTH CAROLINA REGISTER September 15. 1993
PROPOSED RULES
has a comprehensive cardiac services
program; and not farther than 45 road
miles from the facility if the facility
performs only diagnostic cardiac
catheterization procedures.
£9} "Cardiac catheterization services" means
the provision of diagnostic cardiac
catheterization procedures, therapeutic
cardiac catheterization procedures or
electrophvsiology catheterization
procedures.
(10) {§) "Comprehensive cardiac services
program" means a cardiac services
program which provides the full range of
clinical services associated with the
treatment of cardiovascular disease
including community outreach,
emergency treatment of cardiovascular
illnesses, non-invasive diagnostic imaging
modalities, diagnostic and interventional
therapeutic cardiac catheterization
procedures , open heart surgery and
cardiac rehabilitation services.
Community outreach and cardiac
rehabilitation services menf shall be
provided by the applicant or through
arrangements with other agencies and
fecilities located in the same city. All
other components of a comprehensive
cardiac services program must shall be
provided within a single facility.
(11) (6) "Diagnostic cardiac catheterization
procedure" means a cardiac
catheterization procedure performed
using cardiac catheterization or cardiac
angioplasty equipment for the purpose of
detecting and identifying defects or
diseases in the great arteries or veins of
the heart, or abnormalities in the heart
structure.
f^ "Expanded cardiac cath eterization
service " means the addition or conversion
of a room to be dedicated to oardiao
catheterization procedures; ef the
purchase ef additional equipment
specially—designed—te
—
perform—cardiac
catheterizations.
(12) " Elect rophysio logy catheterization
procedure" means a diagnostic or
therapeutic cardiac catheterization
procedure performed to study the
electrical conduction activity of the heart
and characterization of atrial ventricular
arrhythmias utilizing cardiac
catheterization equipment or cardiac
(13)
(14)
(15)
{«^
(16)
(17)
(18)
angioplasty equipment.
"Existing" means the equipment was in
operation prior to the beginning of the
review period.
"High-risk patient" means a person with
reduced life expectancy because of left
main or multi-vessel coronary artery
disease, often with impaired left
ventricular function and with other
characteristics as
American
referenced in
o 1 1 e g e
the
oj
Cardiology/American Heart Association
Guidelines for Cardiac Catheterization
and Cardiac Catheterization Laboratories
(1991) report.
"Mobile equipment" means cardiac
angioplasty equipment
catheterization
or cardiac
equipment and
transporting equipment which is moved
to provide services at two or more host
facilities.
"Pediatric cardiac catheterization
procedure" mean s a cardiac
catheterization procedure performed on a
patient age five or under.
(9) "Percutaneous transluminal coronary
angioplasty (PTCA)" is a interventional
one type of therapeutic cardiac
catheterization procedure used to treat
coronary artery disease in which a
balloon-tipped catheter is placed in the
diseased artery and then inflated to
compress the plaque blocking the artery.
{40) "Primary cardiac catheterization
service area" means a geographical area
defined by the proponent applicant .
which has boundaries that are not farther
than 45 road miles from the facility, if
the facility has a comprehensive cardiac
services program; and not farther than 23
road miles from the facility if the facility
performs only diagnostic cardiac
catheterization procedures.
"Therapeutic cardiac catheterization
procedure" means a cardiac
catheterization procedure performed for
the purpose of treating or resolving
certain anatomical or physiological
conditions which have been determined to
exist in the heart or great arteries or
veins of the heart.
Statutory Authority G.S. 1 31 E- 177(1).
.1614 INFORMATION REQUIRED OF
8:12 NORTH CAROLINA REGISTER September 15, 1993 1029
PROPOSED RULES
APPLICANT
(a) An applicant that proposes a
—
sew—ef
expanded cardiac catheterization service to acquire
cardiac catheterization or cardiac angioplasty
equipment must provide the information requested
eft shall use the acute care facility/medical
equipment application form.
(b) In addition to information requested on the
aouto care application form, th e The applicant must
shall provide the following additional information
based on the population residing within the
applicant's proposed cardiac catheterization service
area :
(1) the projected number of cardiac
catheterization procedures, by CPT or
ICD-9-CM by ty^ classification of
cardiac catheterization procedure^ to be
completed performed in each cardiac
catheterization room for each of the
first 12 calendar quarters following
completion of the proposed project,
including the methodology and
assumptions used for these projections;
(2) documentation of the applicant's
experience in treating cardiovascular
patients at the facility during the past
twelve months, including;
(A) the number of patients receiving stress
tests;
(B) the number of patients receiving
intravenous thrombylitio thrombolytic
therapies;
(C) the number of patients presenting in
the Emergency Room or admitted to
the hospital with suspected or
diagnosed acute myocardial inferction;
and
(D) the number of patients referred to
other facilities for cardiac
catheterization procedures and/or or
open heart surgery procedures, by
type of procedure;
(3) the number of patients from the
proposed service area who are projected
to receive cardiac catheterization
services by patient's county of
residence in each of the first 12
quarters of operation, including the
methodology and assumptions used for
these projections;
(4) the number of patients from the
proposed primary service area who are
projected to receive cardiac
catheterization services by patient's
county of residence in each of the first
12 quarters of operation, including the
methodology and assumptions used for
these projections;
(5) documentation of the applicant's
projected referral sources of patient*
referrals that are located in the
proposed service area, including letters
from the referral sources that
demonstrate their intent to refer patients
to the applicant for cardiac
catheterization services ;
(6) evidence of the applicant's capability to
communicate e fficiently with
emergency transportation agencies and
with an established comprehensive
cardiac services program;
(7) the number and composition of cardiac
catheterization teams available to the
applicant;
(8) a brief description of documentation of
the applicant's in-service training or
continuing education programs for
cardiac catheterization team members;
(9) a written agreement with a
comprehensive cardiac services
program specifying that specifies the
arrangements for referral and transfer
of patients seen by the proponent
applicant which and that includes a
process to alleviates the need for
duplication in catheterization studies;
( 10) a written description of patient selection
criteria including referral arrangements
for high-risk patientsrj
(1 1) a copy of the contractual arrangements
for the acquisition of the proposed
cardiac catheterization equipment or
cardiac angioplasty equipment,
including itemization of the cost of the
equipment; and
(12) documentation that the cardiac
catheterization equipment and cardiac
angioplasty equipment and the
procedures for operation of the
equipment are designed and developed
based on the American College of
Cardiology/American Heart Association
Guidelines for Cardiac Catheterization
Laboratories (1991) report.
Statutory Authority G.S. 131E-177(1).
.1615 REQUIRED PERFORiMANCE
STANDARDS
(a) To be approved th e State Agency must
1030 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
determine The applicant shall demonstrate that the
project is capable of meeting the following
standards:
(1) each proposed item of cardiac
catheterization room equipment or
cardiac angioplasty equipment,
including mobile equipment wiH shall
be utilized at an annual rate of at least
40 60 percent of capacity, measured
during the fourth quarter of the third
year following completion of the
project;
(2) if the facility applicant has—
a
compreh ensive oardiao s ervioea
program—ef—the
—
proponent—intends
proposes to perform elective
—
PTCA
therapeutic cardiac catheterization
procedures, each of the proponent
applicant's therapeutic cardiac
catheterization teams will be performing
shall be performing at an annual rate of
at least 50 PTCA 100 therapeutic
cardiac catheterization procedures,
measured during the fourth quarter of
the third year of operation following
completion of the project;
(3) at least 50 percent of the projected
cardiac catheterization procedures -wiH
shall be performed on patients residing
within the primary service area;
(4) each existing item of cardiac
catheterization room equipment and
cardiac angioplasty equipment in each
facility which has a primary service
area that overlaps the proposed primary
service area shall have been operated at
a level of at least §0 80 percent of
capacity during the 12 month period
reflected in the most recent licensure
form on file with the Division of
Facility Services;
(5) the utilization of each existing or
approved item of cardiac catheterization
programs equipment and cardiac
catheterization angioplasty equipment
whose in each facility which has a
primary service area that overlaps the
proposed primary service area is not
shall not be expected to fell below 40
60 percent of capacity due to the
institution—of the
—
new or—
e
xpanded
program acquisition of the proposed
cardiac catheterization, cardiac
angioplasty, or mobile equipment:
(6) if the applicant proposes to perform
diagnostic cardiac catheterization
procedures, the applicant's—projected
utilization and proposed staffing
patterns are suoh that each diagnostic
cardiac catheterization team -wiH shall
be performing at an annual rate of at
least 150 diagnostic-equivalent
catheterization procedures by the end of
the third year following completion of
the projectT i
(7) each item of existing mobile equipment
in the proposed cardiac catheterization
service area shall have been performing
at least an average of four diagnostic-equivalent
catheterization procedures
per day per site in the proposed cardiac
catheterization service area in the
twelve month period preceding the
submittal of the application; and
(8) each item of existing or approved
mobile equipment to be operating in the
proposed cardiac catheterization service
area shall be performing at least an
average of four diagnostic-equivalent
catheterization procedures per day per
site in the proposed cardiac
catheterization service area in the
applicant's third year of operation.
(b) If the proponent intends applicant proposes
to perform pediatric cardiac catheterization
procedures on patients age five and under, the
State Agency must determine that the proponent
the applicant shall demonstrate that it meets the
following additional criteria:
(1) the fecility has the capability to perform
both pediatric diagnostic and
therapeutic cardiac catheterization
oervioes procedures and pediatric open
heart surgery services on patients age
five and under:
(2) the proposed project wiH shall be
performing at an annual rate of at least
80 150 pediatric cardiac catheterization
procedures on patients age five or
under during the fourth quarter of the
third year following initiation of
pediatric the proposed cardiac
catheterization service for patients age
five and under .
(c) An applicant shall provide documentation of
all assumptions and data used in the development
of the projections required in this Rule.
Statutory Authority G.S. 131E-177(1).
8:12 NORTH CAROLINA REGISTER September 15, 1993 1031
PROPOSED RULES
.1616 REQUIRED SUPPORT SERVICES
(a) If the proponent intendB applicant proposes
to perform elective PH'CA therapeutic cardiac
catheterization procedures, the State Agenoy must
dotormino that the proponent the applicant shall
demonstrate that hao aooooo to—aft open heart
surgery services are provided within the same
facility.
(b) If the applicant proposes to perform
diagnostic cardiac catheterization procedures, the
applicant shall document that its patients will have
access to a facility which provides open heart
surgery services, in close proximity, and that the
patients can be transported to that facility with no
greater risk than if the procedure had been
performed in a hospital which provides open heart
surgery services.
(c) (b) To be approved the State Agenoy must
determine The applicant shall provide
documentation to demonstrate that the following
services wtH shall be available in the facility:
(1) electrocardiography laboratory and
testing services including stress testing
and continuous cardiogram monitoring;
(2) echocardiography service;
(3) blood gas laboratory;
(4) pulmonary function unit;
(5) sfaffed blood bank;
(6) hematology laboratory/coagulation
laboratory;
(7) microbiology laboratory;
(8) clinical pathology laboratory with
facilities for blood chemistry;
121 immediate endocardiac catheter
(10)
pacemaking jn case of cardiac arrest;
and
nuclear medicine services including
nuclear cardiology.
Statutory Authority G.S. I31E-177(l).
.1617 REQUIRED STAFFING AND STAFF
TRAINING
(a) To be approved, th e State Agenoy must
determine that the proponent The applicant shall
provide documentation to demonstrate that eafl
meet the following staffing requirements shall be
met:
(1) one physician licensed to practice
medicine in North Carolina who has
been designated to serve as director of
the cardiac catheterization service and
who has all of the following special
credentials:
(A) board-certified in internal medicine,
(B)
(C)
pediatrics or radiology;
subspecialty training aad
—
board
eligibility' in cardiology, pediatric
cardiology, or cardiovascular
radiology; and
current clinical experience in perform-ing
physiologic procedures,
angiographic procedures, or both;
(2) at least one specialized team to perform
cardiac catheterizations, composed of at
least the following professional and
technical personnel:
(A) one physician licensed to practice
medicine in North Carolina with
evidence of special training and cur-rent
experience in cardiovascular
disease and radiation sciences;
(B) one nurse with special training and
current experience in critical care of
cardiac patients, cardiovascular medi-cation,
and catheterization equipment;
and
(C) at least three technicians with current
specialized training in cardiac care
who are capable of performing the
duties of a radiologic technologist,
cardiopulmonary technician, monitor-ing
and recording technician, and
darkroom technician.
(b) To be approved, the State Agency must
determine that th e proponent The applicant shall
provide documentation to demonstrate that eon
provide the following staff training shall be provid-ed
for members of cardiac catheterization teams:
(1) certification in cardiopulmonary resus-citation
and advanced cardiac life sup-port;
and
(2) an organized program of staff education
and training which is integral to the
cardiac services program and ensures
improvements in technique and the
proper training of new personnel.
Statutory' Authority G.S. 1 31 E- 1 77(1).
.1618 DATA REPORTING REQUIREMENTS
The facility must shall agree to provide^ upon the
request of the Division of Facility Services, the
following types of data and information to the
Division of Facility Services , in accordance with
data format and reporting requirements formulated
by the Division of Facility Services:
(1) demographic data on patients treated;
(2) financial data; and
(3) clinical data.
1032 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
Statutory Authority G.S. 131E-177(1).
.1619 ACCESSIBILITY
(a) The applicant shall provide documentation
describing the mechanism that will be used to
ensure that the projected number of medically
underserved will be served in the facility.
(h) The applicant shall provide written
admissions policies identifying any prepayment or
deposit requirements for the facility and stating the
admission requirements for patients in each of the
following payor categories:
(1) Medicare;
(2) Medicaid;
(3) Blue Cross and Blue Shield;
(4) Commercial Insurance;
(5) State Employees Health Plan;
(6) Self-Pay (includes self-pay, indigent
and charity care); and
(7) Other as identified by the applicant.
(c) The applicant shall provide a written
description of the billing procedures, including the
credit and collection policies that will be utilized
by the facility.
(d) The applicant shall document that the health
care community in the service area, including the
Departments of Social Services and Health, have
been invited to comment on the proposed project,
particularly with regard to the facility's referral
mechanisms and admissions policies for the
medically underserved.
Statutory Authority G.S I31E-I77(1).
SECTION .1700 - CRITERIA AND
STANDARDS FOR OPEN-HEART
SURGERY SERVICES AND HEART-LUNG
BYPASS MACHINES
.1713 DEFINITIONS
The following definitions -wtH shall apply to all
rules in this Section:
(1) "Capacity" of an open heart ourgioal ouite
surgery room i s cons idered to be means
400 adult-equivalent open heart surgical
procedures per year. One pediatric open
heart surgical procedure on persons age
5 and under is valued at two adult open
heart surgical procedures. For purposes
of determining capacity, one open heart
surgical procedure is defined to be one
visit or trip by a patient to the open heart
surgical suite surgery room for an open
heart operation.
(2) "Cardiac Surgical Intensive Care Unit"
m-means
a distinct intensive care unit as
defined in 10 NCAC 3R .1213(2) and
which is for exclusive use by post-surgical
open heart patients.
"Expanded—open—heart—surgical—suite "
means the addition or oonveroion of an
operating room to be dedicated for open
heart surgical procedures.
(3) "Heart-lung bypass machine is defined in
G.S. 131E-176(10a). ^ "Pediatric open heart ourgioal procedure"
means an open heart ourgioal procedure
performed on a patient age five or under.
(4) {9)
" Open heart Service surgery service
area" means a geographical area defined
by the proponent applicant , which has
boundaries that are not farther than 90
road miles from the facility.
(5) "Open heart surgery services" is defined
in G.S. 131E-176(18b).
(6) (^ "Open heart surgical procedures"
means are
—
highly—opeoializod—surgical
prooedureo—which—utilize a heart lung
bypaoo maohine (the "pump") to perform
e xtra corpore al circulation etn4
oxygenation during surgery.—Open heart
surgical procedureo include a wide range
of procedures those surgical procedures
which are identified by Diagnostic
Related Group ("DRG") numbers 104,
105, 106, 107, and 108, and which are
designed to correct congenital and
acquired cardiac and coronary artery
disease.
£7} f4) "Open heart surgical suite surgery
room " means an operating room
dedicated to open heart surgical
procedures^ which has been approved for
this—use
—
by the
—
Certificate—ef
—
Need
Section as reported on the most current
hospital licensure application. , along with
any related rooms used for preparation
and immediate post operative recover)' of
patients receiving an open heart surgical
procedure.
(8) (6) "Open heart surgical surgery
program" includes means all of the open
heart surgical—suites surgery rooms
operated in one hospital.
fT) "Percutaneous—trans luminal—coronary
angioplasty (PTCA) procedure " means an
interventional cardiac catheterization
procedure used to treat coronary artery
disease in which a balloon tipped catheter
is placed in the diseased artery and then
8:12 NORTH CAROLINA REGISTER September 15, 1993 1033
PROPOSED RULES
inflated to oompress the plaque blocking
the arter>'.
(9) {^ "Primary open heart surgery service
area" means a geographical area defined
by the proponent applicant , which has
boundaries that are not ferther than 45
road miles from the facility.
Statutory Authority G.S. 131E-177(1).
.1714 INFORMATION REQUIRED OF
APPLICANT
(a) An applicant that proposes a—new—ef
expanded to add an open heart surgiool—stHte
surgery room or to acquire a heart-lung bypass
machine must provide the information requested on
shall use the acute care facility/medical equipment
application form.
(h) In addition to information requested on the
aouto oare
—
application form, th e The applicant
must shall also provide the following additional
information:
(1) the projected number of open heart
surgical procedures to be completed in
each open heart surgical suite surgery
room and the projected number of open
heart surgical procedures to be
performed on each heart-lung bypass
machine for each of the first 12
calendar quarters following completion
of the proposed project, including the
methodology and assumptions used 4ef
to make these projections;
(2) the projected number of cardiac
catheterization procedures to be
completed in the facility for each of the
first 12 calendar quarters following
completion of the proposed project,
including the methodology and
assumptions used for these projections;
(3) the applicant's experience in treating
cardiovascular patients at the facility
during the past 12 months, including:
(A) the number of patients receiving stress
tests;
(B) the number of patients receiving
intravenous thrombolytic therapies;
(C) the number of patients presenting in
the Emergency Room or admitted to
the hospital with suspected or
diagnosed acute myocardial infarction;
(D) the number of cardiac catheterization
procedures performed, by type of
procedure;
(E) the number of patients referred to
other facilities for cardiac
catheterization or open heart sui^ical
procedures, by type of procedure;
(F) the number of patients referred to
proponent's the applicant's facility for
cardiac catheterization or open heart
surgical procedures, by type of
procedure;
(4) the number of patients from the pro-posed
open heart surgery service area
who are projected to receive open heart
surgical procedures by patient's county
of residence in each of the first 12
quarters of operation for those projco
tions including the methodology and
assumptions used to make the projec-tions
;
(5) the number of patients from the pro-posed
primary open heart surgery ser-vice
area who are projected to receive
open heart surgical procedures by
patient's county of residence in each of
the first 12 quarters, including the
methodology and assumptions used -fef
to make these projections;
(6) the projected patient referral sources ef
patients ;
(7) evidence of the applicant's capability to
communicate efficiently with emergen-cy
transportation agencies and with all
hospitals serving the proposed service
area;
(8) the number and composition of open
heart surgical teams available to the
applicant;
(9) a brief description of the applicant's in-service
training or continuing education
programs for open heart surgical team
members; and
(10) evidence of applicant's the capability to
perform both cardiac catheterization
and open heart surgical procedures en
a 24 hours per day, 7 days per week
Statutory Authority G.S 13IE-177(1).
.1715 REQUIRED PERFORMANCE
STANDARDS
To be approved, th e State Agency must deter
mine The applicant shall demonstrate that the
proposed project is capable of meeting the follow-ing
standardsTj^
(1) each open heart surgioal suite surgery
room mii shall be utilized at an annual
1034 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
rate of at least 50 percent of capacity,
measured during the fourth twelfth quar-ter
of the third year following completion
of the project;
(2) the proponent will be performing a euffi
oient number of applicant shall perform
at least 4 diagnostic catheterizations te
generate the proj ected—number of per
open heart surgical procedures procedure
during each quarter;
0) the proponent will be performing at an
annual mto of at loaot 50 PTCA prooe
duroD. measured during the fourth quarter
of the third year following completion of
the proj ect;
(3) a new or additional heart-lung bypass
machine shall be utilized at 200 open
heart surgical procedures per year, mea-sured
during the twelfth quarter following
completion of the project;
(4) at least 50 percent of the projected open
heart surgical procedures wiU shall be
performed on patients residing within the
primary open heart surgery service area;
(5) each existing open heart ourgioal suite
surgery program in each facility which
has a primary open heart surgery service
area that overlaps the proposed primary
open heart surgery service area operated
at a level of a least 80 percent of capacity
during the 12 month period reflected in
the most recent licensure form on file
with the Division of Facility Services;
(6) the utilization of existing open heart
surgical surgery programs whose primary
open heart surgery service area overlaps
the proposed primary open heart surgery
service area is not expected to fall below
50 percent of capacity due to the institu-tion
of the new or expanded open heart
surgical program; and surgery program;
(7) the applicant's projected utilization and
proposed staffing patterns are such that
each open heart surgical team will be
performing shall perform at an annual
rate of at least 150 open heart surgical
procedures by the end of the third year
following completion of the proj ect.
project;
(8) the applicant shall document the assump-tions
and provide data supporting the
methodology used to make these projec-tions;
and
(9) heart-lung bypass machines that have
been acquired for non-surgical use shall
not be utilized in the performance of
open heart surgical procedures.
Statutory Authority G.S. 131 £-177(1).
.1716 HOURS OF OPERATION
To be approved, the State Agency must deter
mine applicant shall demonstrate that the proponent
has the capability of providing open heart surgical
procedures—34
—
houre—per day,—seven days—per
week.
Statutory Authority G.S. 1 31 E- 177(1).
.1717 REQUIRED SUPPORT SERVICES
(a) To be approved, the State Agency must
determine The applicant shall demonstrate that the
following services witt shall be available on a in
the facility 24 hours per day, 7 days per week
basis in the facility :
(1) electrocardiography laboratory and
testing services^ including stress testing
and continuous cardiogram monitoring;
(2) echocardiography service;
(3) blood gas laboratory;
(4) nuclear medicine laboratory;
(5) pulmonary function unit;
(6) staffed blood bank;
(7) hematology laboratory or coagulation
laboratory;
(8) microbiology laboratory;
(9) clinical pathology laboratory with facili-ties
for blood chemistry;
(10) dedicated cardiac surgical intensive care
unit that shall be a distinct intensive
care unit and shall meet the require-ments
of 10 NCAC 3R .1200 ;
(11) emergency room with full-time director,
staffed for cardiac emergencies with
acute coronary suspect surveillance area
and voice communication linkage to the
ambulance service and the coronary
care unit; and
(12) cardiac catheterization services includ-ing
both diagnostic and interventional
cardiac catheterization capabilities.
(b) To be approved th e State Agency—mus t
determine The applicant shall demonstrate that the
following services 'mU shall be available to the
proponent applicant :
(1) a preventive mainten